System, protective element and dispensing device for monitoring the dispensing of an administerable substance

Abstract

The present invention relates to a system, a detection device, a method, a use and a computer program product for monitoring the preparation, execution and / or post-processing of the actual or simulated dispensing of an administrable, preferably pharmaceutical, preparation, execution and / or post-processing of the actual or simulated dispensing, hereinafter referred to as the dispensing process, using a dispensing device for dispensing the substance, wherein the dispensing device has at least one sound generator, the at least one sound generator being designed to generate at least one sound event in an acoustic signal during the dispensing process, the at least one sound event being specific to a characteristic or state change of the dispensing device, and using a detection device for checking the acoustic signal for the at least one sound event so as to enable detection of a characteristic or state change of the dispensing device.

Description

[0001] The present invention relates to monitoring the actual or simulated dispensing preparation, execution and / or post-processing of an administrable, preferably pharmaceutical, substance.

[0002] The invention relates in particular to monitoring the dispensing of an administrable substance in connection with monitoring the operation of a dispensing device or in connection with the determination of so-called patient compliance (also called compliance or adherence).

[0003] In the case of operation monitoring, the progress of the actual or simulated dispensing of an administrable or medicinal substance is monitored with respect to indicators which indicate or do not indicate a proper or complete operation, in particular an administration.

[0004] In order to determine patient compliance, the extent and / or intervals of taking the medication are monitored. The results of the monitoring, in particular the information about the actual administration or medication, can then be checked to determine whether the latter corresponds to a preset value (which can be in the form of a physician's prescription, for example) or deviates therefrom.

[0005] Based on the results of the operation monitoring or the determined patient compliance, measures can be automatically initiated. In particular, such measures are initiated when a malfunction is determined (possibly due to a technical defect or an operating error) or the administration of the medicament deviates from this preset value.

[0006] Both the results of operational monitoring and the determined patient compliance can be used as a measure to notify or alert the user (patient) or a third party (such as a medical practitioner or medical system).

[0007] US 7,002,476 B2 relates to a medicament dispensing device coupled to a transceiver for wireless control, the transceiver accessing a set of control data from a server. A set of instructions is downloaded to instruct a user via the transceiver how to use the dispensed medication.

[0008] To protect the drug, an audible or visible indication may be given after the time has elapsed.

[0009] US 7,093,736 B2 relates to an arrangement with a blister that can be moved between two positions. An alarm is given when a cycle has ended. When the blister is touched for the purpose of removing a dose, the alarm unit is reset. For this purpose, a special device with a mechanism and a sensor system is proposed, which is designed to monitor the touching of the blister.

[0010] It is an object of the present invention to simplify or improve the monitoring of actual or simulated dispensing of an administrable substance.

[0011] This object is achieved by a system, a detection device, a method, a use, a protection element or a dispensing device according to what is described herein. Advantageous further developments are also given herein.

[0012] A first aspect of the invention relates to a system for preferably acoustically monitoring the preparation, execution and / or post-processing of an actual or simulated dispensing of an administrable, preferably pharmaceutical substance. Such actual or simulated dispensing preparation, execution and / or post-processing are hereinafter combined under the term "dispensing process".

[0013] The system according to the proposed solution has, on the one hand, a dispensing device for dispensing the substance and, on the other hand, a detection device for checking the acoustic signal.

[0014] For the purposes of the present invention, the term "dispensing device" is defined as a device designed to dispense a substance for the purpose of administration. The dispensing device is preferably a device for dispensing one or more doses or portions of the substance, which doses or portions (in each case) are suitable for complete and / or direct administration to a patient due to their amount, their volume and / or their form.

[0015] Thus, on the one hand, the term "dispensing device" includes packages such as blisters or containers such as reservoirs from which a drug or other administrable substance can be removed for administration purposes. In this case, the substance can be removed manually, in particular in discrete individual doses (e.g. as capsules or tablets) or in the form of powders or granules. Other examples of dispensing devices are injection systems, such as automatic syringes and syringes, sprayers, inhalers, or dispensers for liquids, creams or gels.

[0016] For the purposes of the present invention, the term "actual dispensing" is defined as the latter resulting or will result in the administration of a substance. In this case, this may be the injection of an injectable solution, the spraying of an inhalable substance, or the removal from a manually disposable substance package.

[0017] For the purposes of the present invention, the term "simulated dispensing" is defined as the operation of a dispensing device for testing or training in which a substance can be administered, without this operation leading to or being capable of leading to the administration of said substance, or wherein said substance is a placebo. However, said operation is performed in the same way or similarly to the operation of the dispensing device for actual dispensing or administration. In this context, it is meant in particular the preparation and operation of a dispensing device containing a placebo, for example a placebo inhaler for inhalation training or a placebo autoinjector for injection training.

[0018] When only "dispensing" is meant hereinafter, this includes actual dispensing, simulated dispensing, or a combination of simulated and actual dispensing, unless otherwise explicitly described or obvious from the context.

[0019] "Administrable" preferably means that the material is suitable and intended for direct application to a patient (human or animal) or for direct ingestion by a patient, and / or is present in a dosage form and amount conventionally used for personal, medical or clinical use.

[0020] The dispensing device according to the proposed solution has at least one sound generator.For the purposes of the present invention, a structure designed to generate or trigger a sound event in an acoustic signal is referred to as a "sound generator".

[0021] In this case, the sound generator may be provided in particular for the purpose of sound generation, or may be formed by a structure that serves another primary purpose but generates or triggers a sound event when in use. The sound generator may be arranged in one or more components and in one or more locations of the dispensing device and / or the packaging of the dispensing device.

[0022] The sound generator preferably consists of at least two parts or sections which correspond to each other and which, when moved or separated relative to each other, generate or trigger the sound event.

[0023] For the purposes of the present invention, the generation of sound waves and the generated sound waves are collectively referred to as a "sound event". For the sake of clarity, the term "sound event" thus combines the process of exciting acoustic oscillations and the result of the propagating sound waves generated in this way, since the latter do not directly correspond to each other.

[0024] The sound event may extend over a limited time path. The sound event is preferably an acoustic pulse, pulsation and / or has a temporary nature. The sound event is preferably short, for example shorter than 10 seconds, 5 seconds or 2 seconds. It may also be shorter than 1 second or 0.5 seconds.

[0025] The sound event generates or is preferably a sound wave having a frequency that is preferably audible and / or can be converted into an electrical signal by a commercially available microphone, for example between 100 Hz and 20 kHz. Alternatively or additionally, the sound event can generate or be ultrasound, for example between 20 kHz and 200 kHz.

[0026] The sound event may be a noise or a tone. For example, the sound event may be a click, a clack, a bang, a hiss, a buzz, or a beep.

[0027] For the purposes of the present invention, an "acoustic signal" is a sound wave or information corresponding thereto, for example, a corresponding current or a corresponding voltage, a spectrum or a digital pendant of a sound wave. Thus, the acoustic signal may exist both as a sound wave and in the form of a current and / or voltage converted and / or digitized into digital data, wherein more current and / or voltage and / or data correspond to the sound wave or represent the sound wave. It is not necessary but preferred that the acoustic signal exists in the form of digital data, a data stream, an audio sample, etc. and is processed electrically and / or digitally.

[0028] The acoustic signal has the sound event. This can be done by having the acoustic signal imprinted by the sound event. Thus, the acoustic signal can be a time trace of a sound wave in segmented form that the sound event has, or a time trace of a sound wave on which the sound event is superimposed in the form of a sound wave. Alternatively or additionally, the acoustic signal is information corresponding to this sound wave, the information comprising information originating from the sound event.

[0029] The sound event is specific to a characteristic or state change of the dispensing device. In this way, the sound event preferably enables (clear) identification of the dispensing device or the substance and / or assignment of the dispensing device to a group or class of dispensing devices or substances. In this case, the possible identification of the substance is a characteristic of the dispensing device, because the dispensing device has the substance or is designed for this purpose. Alternatively or additionally, due to the specificity, the sound event can enable detection of a state change in the form of triggering, actuating, unlocking, tightening, substance ejection, or packaging or unpacking.

[0030] While a sound event may be different from other sound waves from other sources, the sound event is specific to a characteristic or state change of the dispensing device and thus enables assignment or identification.

[0031] The term "specific" therefore means that the sound event is different from other sound events or can be identified independently of other sound events, preferably so that the sound event can be assigned to a characteristic or a change of state of the dispensing device and thus by means of the detection of the sound event the dispensing device, the characteristic or the change of state of the dispensing device and / or the substance, or a group or class thereof, can be identified. This includes in particular the detection or differentiation of events such as preparation, dispensing and / or triggering.

[0032] For example, in the case of different substances, the same type of dispensing device can be designed to generate different sound events by various sound generators in order to distinguish substances in the case of otherwise identical dispensing devices. In this way, the corresponding sound events are specific to the substances.

[0033] Alternatively or additionally, dispensing devices of different designs may have a sound generator for generating the same sound events, so that the same substance can be identified even if the dispensing devices are designed differently.

[0034] Furthermore, dispensing devices of the same design or category may have a sound generator for generating the same sound events in order to detect the same design or category and / or generating different sound events in order to be able to distinguish dispensing devices of the same design or category from each other.

[0035] The sound generator is designed to generate at least one sound event in the case of preparation, execution and / or post-processing of the dispensing of a substance. The generation preferably occurs as a by-product of the dispensing process.

[0036] For the purposes of the present invention, the term "dispensing process" generally combines: the preparation, execution and / or post-processing of the actual or simulated dispensing of the substance. In this case, preferably only the necessary steps are meant, i.e. those steps that are absolutely necessary for dispensing the substance by proper use of the dispensing device. Such absolutely necessary steps may be: for preparing the removal of packaging or protective parts; for achieving a trigger (without which the dispensing cannot be performed); and / or for post-processing measures necessary for removing the dispensing device from the patient and / or for reuse.

[0037] Preferably, the sound event is generated or in any case is generated in the case of direct dispensing or as a step directly accompanying the dispensing of a substance. The sound generator is therefore designed to generate the sound event in the case of direct dispensing or as a step directly accompanying the dispensing of a substance. An example here is the phase that triggers the dispensing or the substance leaves the dispensing device. However, there can be multiple sound events, not all of which must be generated by a step directly dispensing or directly accompanying the dispensing of a substance.

[0038] Furthermore, the system according to the proposed solution has a detection device for checking the acoustic signal in the at least one sound event.Due to this checking, a property or state change of the dispensing device can be detected or assigned, or this is performed by the detection device.

[0039] In particular, the detection device detects or distinguishes the dispensing device, a change in a property or state of the dispensing device, and / or a substance by examining the acoustic signal in the at least one sound event.

[0040] In other words, the detection device is therefore designed to check and detect the sound signal in the sound event originating from the dispensing device and generated by the sound generator: whether the sound signal has a sound event that is specific to the dispensing device, a characteristic or state change of the dispensing device and / or a substance.

[0041] The "detection or assignment" of a property or a change of state can in principle be or include an individual identification of a specific dispensing device or substance, or the detection of a dispensing device or substance in a specific group or type of dispensing devices or substances. Thus, the detection of a property of the dispensing device can be the detection of the dispensing device as such, but can also consist in detecting an event (such as, for example, direct dispensing) using the dispensing device, as opposed to, in any case, also the detection of a dispensing device or its group or class and / or substance and, in addition, a specific state or a specific change of state. By checking the acoustic signal for the at least one sound event, the sound event is preferably only detected if it originates from the dispensing process.

[0042] For the purposes of the present invention, a "detection device" is therefore primarily a device that is configured to analyze an acoustic signal. For example, it may have a processor, in particular a signal processor, or other analysis means for processing and evaluating an audio signal in order to perform this functional range. Moreover, the detection device is specifically configured for checking. This means that the detection device is optionally suitable for distinguishing different sound events in an acoustic signal or detecting a specific sound event or distinguishing it from other sound events based on additional information.

[0043] In order to be able to detect the sound event, the detection device preferably has corresponding information in the form of a sound event pattern. The sound event pattern can also be a signature of the sound event. Using the sound event pattern, the detection device can compare the acoustic signal and detect when the sound event occurs in the acoustic signal.

[0044] The system according to the proposed solution enables in an advantageous manner to monitor the dispensing process for dispensing the substance by testing the acoustic signal. Thus, it is easy to check whether the correct substance is applied and / or whether the application is fully performed, and optionally whether the application is performed correctly (i.e. as specified).

[0045] In this case, the detection device can be produced in a particularly simple and effective manner by a smartphone or another, in particular portable, device with a microphone and a processor. Thus, specific hardware or expensive electronic implementations in the dispensing device can be avoided. The detection device can have one or more (software) modules, which can perform the functions of the detection device.

[0046] Furthermore, the inspection of the acoustic signal and the detection of the acoustic event enable many applications, which may be implemented by the detection device or enabled externally or in some other way. In one example, the detected or performed dispensing process is reconciled to a preset value or used in another way to check the provided or preset medicine. Alternatively or additionally, the inspection or the result of the inspection is used to detect a malfunction or incorrect application of the dispensing device and optionally to prompt troubleshooting such as error signaling.

[0047] In order to generate specific sound events, in many cases it is sufficient to modify a known dispensing device in an advantageous manner without modifying it at all, only slightly, or only for some of the many sound events provided or for a sound generator specifically for generating sounds, so that a specific sound event or events are generated in the case of the dispensing process.

[0048] As a result, a system according to the proposed solution will be implementable reliably, quickly, easily and to a large extent utilizing existing hardware in an unforeseen way and allow universal use, i.e. particularly advantageously in connection with patient compliance (compliance / adherence), operational monitoring and / or application monitoring.

[0049] Another aspect of the invention relates to a detection device for detecting a dispensing process of a preferred medicinal substance, the dispensing process being performed using a dispensing device of the system by testing an acoustic signal generated by a sound generator of the dispensing device for one or more sound events specific to the dispensing device and / or the substance.

[0050] Another aspect of the invention, which can also be realized independently, relates to a method for monitoring the actual or simulated dispensing of an administrable, preferably pharmaceutical, substance using a dispensing device. In particular, this aspect relates to the detection of the dispensing. In this case, an acoustic signal is examined to detect or distinguish the dispensing device, a characteristic or state change of the dispensing device, and / or the substance from acoustic events that can be generated using a sound generator of the dispensing device during a dispensing process, including preparation, execution, and / or post-processing of the dispensing.

[0051] Another aspect of the invention which can also be implemented independently relates to the use of a mobile terminal device for detecting the actual or simulated dispensing of an administrable, preferably pharmaceutical, substance performed using the dispensing device, wherein the mobile terminal device is used to pick up sound signals and test the sound signals for sound events, which sound events can be generated by the dispensing device during the dispensing process and are specific to the dispensing device, its characteristics or state changes and / or the substance.

[0052] Another aspect of the invention, which can also be realized independently, relates to a computer program product having program code means which, when implemented, for example, on a processor, implement the method according to the proposed solution for detection. In particular, this is preferably a non-volatile computer-readable storage medium having instructions, in particular in the form of code, which, when implemented on a processor, implement or carry out the steps of the method according to the proposed solution.

[0053] Another aspect of the invention, which can also be realized independently, relates to a protective element for a dispensing device for dispensing an administrable, preferably medicinal substance. Preferably, the protective element is configured in the form of a cap and / or a cover or lid. The protective element has or forms a sound generator, which is designed to generate at least one reproducible sound event in the acoustic signal when preparing for the actual or simulated dispensing of the substance, the sound event being specific to a property and / or a state change of the dispensing device.

[0054] The protective element is preferably configured to generate the sound event when the protective element is removed from the body of the dispensing device, wherein the generated sound event is independent of the speed, force and / or other external parameters used to remove the protective element from the body. This facilitates the generation of reproducible sound events and facilitates reliable detection of the sound events.

[0055] The protective element preferably has a first part and a second part, the first part and the second part being movable relative to each other between an initial position and an activated position, preferably wherein the initial position and the activated position are different positions of the protective element. This supports the generation of reproducible sound events.

[0056] The sound generator is preferably configured to generate the sound event after the protection element is moved from the initial position to the activated position and / or when the protection element returns from the activated position to the initial position. This facilitates reproducible generation of the sound event.

[0057] Another aspect of the invention, which can also be realized independently, relates to a dispensing device for dispensing an administerable substance. The dispensing device has a body and a protective element, in particular configured as described above.

[0058] Another aspect of the present invention, which can also be realized independently, relates to a system having the dispensing device.

[0059] For the purposes of the present invention, substances suitable for ingestion by or otherwise administration in the human or animal body are referred to as "administrable substances", which substances may be in the form of liquids or suspensions (e.g. for aerosol formation or injection), tablets, capsules, powders or granules.

[0060] The present invention very preferably relates to the administration of a pharmaceutical substance in the form of a medicament, but in principle is not limited thereto. It is therefore not excluded that the present invention or aspects of the present invention may also be advantageous independently of the administration of a medicament. For the purposes of the present invention, the term "administrable substance" therefore also includes substances that can be administered and are not strictly medicaments in addition to pharmaceutical agents.

[0061] For the purposes of the present invention, a "drug" substance is a pharmaceutical agent or medicament having an active ingredient for the treatment or prevention of a disease in humans or animals. Preferably, for the purposes of the present invention, dietary supplements whose dosage form corresponds to that of the pharmaceutical agent are also considered to be among the pharmaceutical substances. Alternatively or additionally, the substance may be a cosmetic.

[0062] Further advantages, aspects and features of the invention emerge from the description of preferred embodiments described herein and below based on the accompanying drawings.

[0063] FIG1 shows a system according to the proposed solution;

[0064] FIG. 2A shows a view of a dispensing device of the system according to the proposed solution of FIG. 1 ;

[0065] FIG. 2B shows a partial cross section of the dispensing device according to FIG. 2A ;

[0066] FIG3 shows a schematic diagram of a detection device;

[0067] FIG. 4 shows a system with a packaged dispensing system according to the proposed solution of FIG. 1 ;

[0068] FIG. 5 shows a system with an opened package according to the proposed solution of FIG. 4 ;

[0069] FIG. 6 shows a time course of an acoustic signal as it may be generated by a dispensing process using a system with a packaged dispensing device according to the proposed solution;

[0070] FIG. 7 shows another dispensing device according to the proposed solution

[0071] FIG8A shows a dispensing device according to a third embodiment in an initial state;

[0072] FIG8B shows a dispensing device according to a third embodiment in an intermediate state;

[0073] FIG8C shows a dispensing device in an activated state according to a third embodiment;

[0074] FIG9 shows an exploded view of a dispensing device according to a third embodiment;

[0075] FIG10 shows an exploded view of a first part and a second part of a protection element according to the proposed solution;

[0076] FIG. 11A shows a schematic cross section of a protection element in an initial position;

[0077] FIG. 11B shows a schematic cross section of the protection element in the activated position;

[0078] FIG. 12A shows a schematic diagram of the protection element according to FIG. 11 in an initial position;

[0079] FIG. 12B shows a schematic diagram of the protection element according to FIG. 11 in the activated position;

[0080] FIG. 13 shows a bottom view of the protection element according to FIG. 11 ; and

[0081] Fig. 14 schematically shows another embodiment of a protection element according to the proposed solution.

[0082] In the drawings, even if the description is not repeated, the same or similar parts are identified by the same or similar reference numerals and may have similar advantages, characteristics and functions. In addition, reference is made to the definitions and statements cited in the general description section.

[0083] FIG. 1 shows a system 1 according to the proposed solution for acoustically monitoring the preparation, execution and / or post-processing of the dispensing of an administrable, preferably pharmaceutical, substance 2 .

[0084] The system 1 has a dispensing device 3 for dispensing a substance 2. The dispensing device 3 in turn has a sound generator 4 for generating at least one sound event in an acoustic signal 6 that is specific to a property or state change of the dispensing device 3 during preparation, execution and / or post-processing of the dispensing of the substance 2.

[0085] Said preparation, execution and / or post-processing are also referred to below as the dispensing process. However, the phase in which the substance 2 leaves the dispensing system 3 is referred to as (direct) dispensing.

[0086] Furthermore, the system 1 preferably has a detection device 7 for checking the acoustic signal 6 for the at least one sound event 5A-5E in order to enable detection of a property or a change in state of the dispensing device 3. The detection device 7 is preferably designed for detecting or distinguishing the dispensing device 3, a property or a change in state of the dispensing device 3 and / or the substance 2 by checking the acoustic signal 6 for the at least one sound event.

[0087] In the example according to Fig. 1, the dispensing device 3 is a so-called autoinjector. In principle, however, the invention can be applied in a corresponding manner to other dispensing devices 3, as will be explained in more detail below based on such an autoinjector.

[0088] FIG. 2A shows a view of a dispensing device 3 , which is in the form of an automatic injector, for example, while FIG. 2B shows a partial section through the dispensing device 3 from FIG. 2A .

[0089] As indicated in the cross section according to FIG. 2B , the dispensing device 3 has at least one administrable dose of a substance 2 , here a syringe 3A filled with the substance 2 and having an injection needle 3B.

[0090] The dispensing device 3 can be triggered, when the substance 2 is administered. To this end, the syringe 3A with the injection needle 3B is moved in an abrupt manner from the dispensing device 3 in order to penetrate into the patient's tissue by means of the injection needle 3B and inject the contents of the syringe 3A (ie the substance 2).

[0091] In order to trigger the dispensing, an actuator 3C is provided at the dispensing device 3. In this illustrative example, the actuator 3C is a tube segment or sleeve, which is pushed into the dispensing device 3 for triggering when the dispensing device 3 is attached to the patient and in this way causes a triggering process, which causes the syringe 3A to move and administer the substance 2. However, in the case of other dispensing devices 3, the actuator 3C can also be realized differently. In the initial state of the dispensing device 3, the triggering is prevented by the protective element 3D. In this example, the protective element 3D is a cap, which prevents the triggering and / or the dispensing of the substance 2.

[0092] However, alternatively or additionally, other protective elements 3D may also be provided, which prevent dispensing or triggering in the initial state of the dispensing device 3. The protective element 3D may be unlocked to enable subsequent triggering and / or dispensing. In the illustrative example, the protective element 3D in the form of a cap is removed, and triggering may only occur when or once the protective element 3D is removed.

[0093] Preferably, the protective element 3D of the dispensing device 3 has or forms the one or more sound generators 4A (or one of them). In this case, the protective element 3D can keep the substance 3 from being dispensed in the initial state, and can be transformed into an activation state for initiating the dispensing of the substance 2 with the generation of the sound event 5A.

[0094] Here, the protective element 3D forms a sound generator 4A together with the part of the dispensing system 3 on which the protective element 3D is arranged in the initial state (locked push-on cap). In the illustrative example, the cap forms the sound generator 4A in such a way that it forms a cylinder-piston unit with the other dispensing device 3, by which a negative pressure is generated in the hollow space formed by the cap when the cap is removed or opened. In the case of complete removal or opening (start-up state), ambient air flows into this hollow space, thereby generating a plop noise known to correspond to the opening or removal of the cap.

[0095] Sound generator 4A is preferably a structure that is not required by the distribution process or distribution, is not directly involved in the distribution and / or is specially designed or modified for generating sound events 5A.

[0096] In this example, the sound generator 4A is a structure of the dispensing device 3 that is specific for or modified for sound generation, the device being designed to generate sound events 5A that are specific to the dispensing device 3 , a property or state change of the dispensing device 3 and / or the substance 2 .

[0097] In this example, the sound generator 4A has a surface structure 3E and a counter structure 3F or is formed in this way, which structures are optionally designed for a dispensing process and generate or modify sounds during operation specifically for this purpose, i.e., sound events 5A are generated by the sound generator 4A in a manner specific to the dispensing device 3, a property or state change of the dispensing device 3 and / or the substance 2.

[0098] In the example, the protective element 3D (inner wall of the cap) has a surface structure 3E which interacts with a counter structure 3F of the dispensing device 3 in such a way that a sound event 5A is generated or modified during unlocking (here, ie, removing or opening the cap). The surface structure 3E with the counter structure 3F forms a sound generator 4A or part thereof.

[0099] Here, for example, ribs, beads or grooves engaging one another are provided. When the cap is removed, these structures lead to oscillations of the protective element 3D or the housing of the dispensing device 3 and thus to sound waves as sound events 5A, which are generated by and correspond to such oscillations.

[0100] This sound wave generated by the modified structure precedes the plop noise in the example and may partially overlap with the plop noise.

[0101] In this way or a similar way, a specific sound event 5A can be caused by a specific or modified structure, and different sound events 5A can be caused by possibly different configurations of surface structures and opposing structures 3E, 3F, even when the dispensing device 3 can be identical with respect to its dispensing-related design.

[0102] However, in any case, the one or more sound generators 4A do not necessarily have to have a modified structure in order to generate a specific sound event 5A. In particular, for identifying a group or category of dispensing devices 3 or identifying the dispensing carried out therewith, it may be sufficient to monitor or detect the sound events 5A accompanying the dispensing process without modifying the existing dispensing devices 3 for this purpose. The sound generator 4A is then an existing structure that generates the sound in the case of a dispensing process. The sound event 5A may be specific enough for detection, especially in the case of more complex dispensing devices 3.

[0103] Thus, the sound generator 4A, 4B may be an already existing or prepared structure of the dispensing device 3 or necessary for dispensing the substance 2, or may be specially formed or modified for this purpose.

[0104] The one or more sound generators 4A are preferably designed such that the sound event 5A or the plurality of sound events 5A during dispensing are generated necessarily and in a reproducible manner.

[0105] In the illustrative example, this is achieved in such a way that a sound generator 4A can be generated which causes the protection element 3D to be unlocked (removed) before triggering, by which sound generator the sound event 5A is generated.

[0106] However, the inevitable generation of the sound event 5A can also be achieved in some other way. For example, the trigger mechanism can form the sound generator 4B so that the sound event 5B is inevitably generated with the trigger (refer to Figure 1).

[0107] For the sound generator 4B of the triggering mechanism and the further or different sound generators 4A, 4B, the features and characteristics explained with respect to the sound generator 4A of the protection element 3D apply correspondingly, unless otherwise stated or the context indicates otherwise.

[0108] In principle, the sound generator 4A, 4B can be based on various measures for sound generation. In particular, the sound generator 4A, 4B can be or have a ratchet, a clapper, a vibrating bell, a rattle, a ringer or a structure for generating a reproducible plop, snap, click, screech, rattle, grating, rattle, hiss, squeak, buzz, ring, or can be or have a vibration caused by a stick-slip effect.

[0109] For example, due to the movable part moving in a ratchet-like manner on the sound generator 4B generated by the trigger, the dispensing device 3 can generate a clicking sound as a sound event 5B. In a corresponding manner, another specific sound event 5B can be generated by performing a dispensing of the substance 2 or using another sound generator 4B during the performance of the dispensing of the substance.

[0110] In one aspect of the invention, the dispensing device 3 has at least two different sound generators 4A, 4B. These sound generators are preferably designed so that, in each phase of the dispensing process that is temporally successive to one another, a first sound event 5A and a second sound event 5B, preferably spaced apart in time and preferably different from the first sound event, are generated.

[0111] In one aspect of the invention, the dispensing device 3 has a plurality of sound generators 4A, 4B or a sequence system with a plurality of sound generators 4A, 4B for generating a sequence of at least or more than two sound events 5A, 5B which (necessarily) follow one another in time during the course of the dispensing process. In this way, the acoustic signal 6 is imprinted with a sequence.

[0112] The sequence system may firstly consist of two or more sound generators 4A, 4B or have the latter. Moreover, it is preferred that the sequence system or the dispensing device 3 is coupled to the latter in such a way that during the dispensing process the sound generators 4A, 4B generate sound events 5A, 5B in a specific sequence. In this case, the sequence system is not necessarily a separate system, but can also be produced by the design of the dispensing device 3 or by its components.

[0113] In the illustrative example, the dispensing device 3 is designed so that a first sound event 5A is first generated using the first sound generator 4A of the protection element 3D, and then a subsequent second sound event 5B is generated or can be generated by the second sound generator 4B of the trigger mechanism, then such a sequence is formed. In this case, the dispensing device 3 implements a sequence system by design. However, alternatively, the sequence system can also be a separate component. In addition, in the case of the dispensing device 3, there are other possibilities for generating a sequence with more than two sound events 5A, 5B or providing sound generators 4A, 4B for this purpose.

[0114] In another aspect, the system 1 preferably has a plurality of dispensing devices 3, which are distinguished with respect to the substances 2 and the sound generators 4A, 4B and are otherwise designed identically or similarly. In this way, the same acoustic signal 6 can be generated by dispensing devices 3 with identical properties with respect to the substances 2. In addition, different sound generators 4A, 4B or acoustic signals 6 can be generated by dispensing devices 3 with various properties with respect to the substances 2. This makes it possible to distinguish the various substances 2 themselves in the case of otherwise at least substantially identical dispensing devices 3.

[0115] Preferably, the one or more sound generators 4A, 4B necessarily and in a reproducible manner generate the one or more sound events 5A, 5B in a specific sequence during the dispensing process. This is ensured for the first sound event 5A in such a way that the protective element 3D must be removed or unlocked before the dispensing of the substance 2 can be performed. Furthermore, this is ensured for the second sound event 5B in such a way that the second sound event 5B is generated by triggering such a dispensing; therefore, the dispensing of the substance 2 is necessarily accompanied by the generation of the second sound event 5B by the second sound generator 4B. However, there are also other possibilities for achieving such a necessary and reproducible sequence of sound events 5A, 5B during the dispensing process.

[0116] An aspect of the invention that can also be realized independently relates to the detection of the dispensing of an administrable, preferably pharmaceutical substance 2 performed or simulated using a dispensing device 3. In this case, the acoustic signal 6 is tested for sound events 5A in the acoustic signal 6 that are specific to the dispensing device 3, a property or state change of the dispensing device 3 and / or the substance 2.

[0117] The sound events 5A, 5B for which the test sound signals 6 are specific to or characteristic of the dispensing device 3, of a property or state change of the dispensing device 3 and / or of the substance 2, and in particular of the preparation, execution and / or post-processing of the dispensing of the substance 2 or of the dispensing process of the substance 2 by means of the dispensing device 3. The sound events 5A, 5B are preferably generated during this dispensing process. The sound events 5A, 5B are preferably specific to or characteristic of the dispensing process or a step in the latter.

[0118] By testing the acoustic signal 6 for the at least one sound event 5A, 5B, a dispensing device 3, a property or state change of a dispensing device 3 and / or a substance 2 can thus be detected or differentiated. This includes the detection or differentiation of groups or categories of dispensing devices 3 or substances 2.

[0119] An example of detecting a dispensing device 3 , a property or state change of a dispensing device 3 and / or a substance 2 by checking the acoustic signal 6 for the at least one sound event 5A, 5B is explained in more detail below based on FIG. 1 .

[0120] In phase 1, the dispensing device 3 is prepared for triggering by unlocking the dispensing device 3 from the protective element 3D. This preparation or unlocking of the protective element 3D (in this example, the removal of the cap) generates a first sound event 5A. In the illustrative example, for this purpose, the protective element 3D is equipped with a sound generator 4A, which is designed and arranged to generate a sound event 5A during the unlocking (removal of the cap).

[0121] The sound event 5A is represented by an (indicated) acoustic oscillation in the sound signal 6. The sound event 5A is moved into the sound signal 6 in such a way that the sound generator 4A generates a sound wave which forms part of the sound signal 6.

[0122] In the illustrative example, the dispensing device 3 has as a first sound generator 4A a protective element 3D, which is preferably designed in a cap-like manner and generates a plop noise during the unlocking process (i.e. in the case of preparation for dispensing of the substance 2). As already explained previously, the protective element 3D can in particular optionally and preferably be provided or modified for generating a specific sound event 5A (here a modified plop noise).

[0123] In phase II according to Fig. 1, the dispensing device 3 is triggered, which in turn causes a sound event 5B, which is represented by an indicated acoustic oscillation in the acoustic signal 6. In this example, the dispensing device 3, which is designed as an automatic injector, is triggered by being attached to the patient with an actuator 3C or in another way. In this case, the triggering and / or direct dispensing of the substance 2 generates the sound event 5B.

[0124] To generate the second sound event, the dispensing device 3 has a second sound generator 4B, which is realized here by a trigger mechanism of the dispensing device 3. This trigger mechanism generates a click sound, followed by a softer continuous noise and an optional click sound at the end of the injection process.

[0125] In its time course, the acoustic signal 6 therefore contains a plurality of different acoustic events 5 which, in this example, originate on the one hand from the preparation and on the other hand from the execution of the (direct) dispensing of the substance 2 using the dispensing device 3 .

[0126] However, the acoustic signal 6 may also have other acoustic events 5A, 5B which do not originate from the distribution system 3 or from other steps. The latter may be ignored and / or discarded and / or marked as features for exclusion.

[0127] The acoustic signal 6 is picked up and processed by a detection device 7. The detection device 7 may be advantageously implemented in the system 1 and may be independent of the system 1 and other parts of the system 1. It therefore represents a separate aspect of the present invention.

[0128] The detection device 7 is designed to detect a change in a characteristic or state of the dispensing device 3, or the dispensing device 3 and / or the substance 2, in such a way that the detection device 7 tests a sound signal 6 for one or more sound events 5A, 5B, wherein the one or more sound events are generated by at least one sound generator 4 of the dispensing device 2 and are specific to the change in a characteristic or state of the dispensing device 3, or to the dispensing device 3 and / or the substance 2.

[0129] Preferably, in case at least one sound event 5A, 5B is detected in the sound signal 6, the detection device 7 determines a property or a state change of the dispensing device 3 or the dispensing device 3 and / or the substance 2 based on the detected sound event 5A, 5B.

[0130] The detection device 7 preferably has a microphone 8 , via which the acoustic signal 6 with the sound events 5A, 5B is picked up.

[0131] Furthermore, the detection device 7 preferably has a processor 9 for managing the acoustic signal 6. In particular, the processor 9 is a signal processor (also referred to as a digital signal processor (DSP)) or has such a signal processor. In this case, this is a processor 9 or a part thereof having a computing structure that is particularly suitable or designed to process audio signals. The use of a signal processor has proven to be particularly advantageous, because the signal processor processes the acoustic signal 6 particularly effectively and efficiently, especially when it continuously monitors the continuous acoustic signal 6.

[0132] The detection device 7 preferably digitizes and digitally processes the acoustic signal 6. For this purpose, the detection device 7 can have an analog-to-digital converter (ADC) to convert the acoustic signal 6 converted by the microphone 8 into an analog electrical signal 6 into a digital acoustic signal 6. However, in principle, analog processing is also possible.

[0133] The detection device 7 detects or distinguishes the dispensing device 3 and / or the substance 2 by preferably continuously checking the acoustic signal 6 for the at least one acoustic event 5A, 5B. Therefore, it is preferred that the signal 6 is checked over an extended period of time without interruption in order to identify the acoustic events 5A, 5B in the acoustic signal 6.

[0134] The detection device 7 may optionally have an output device 10 for outputting the result of the examination of the acoustic signal 6 or for signaling the detection or differentiation or its characteristic value. The output device 10 may be or have a display, a loudspeaker and / or another user interface.

[0135] In another aspect of the invention, the detection device 7 has an interface 11 for generating a data link 12, for example to a database 13. The database 13 may form part of the system 1 or be provided as an external database 13 separate therefrom.

[0136] The detection device 7 is particularly preferably designed to detect or differentiate at least two preferably different sound events 5A, 5B which are in each case specific to the dispensing device 3 and / or the substance 2. This is done by checking the acoustic signal 6 for these sound events 5A, 5B.

[0137] Preferably, the detection device 7 has an analysis device 15 for testing the different sound events 5A, 5B detected under examination against a predetermined sequence or order, or forms such an analysis device.

[0138] The detection device 7 is preferably designed to output a result 14 via the output device 10 when a certain sequence of various sound events 5A, 5B that is specific to or characteristic of the allocation process has been detected by the detection device 7 or the analysis device; and to output an error when a sequence, amount or number of different sound events 5A, 5B that deviates therefrom has been detected.

[0139] Particularly preferably, the detection device 7 is designed to differentiate between different sound events 5A, 5B of identical, similar or different dispensing devices 3 .

[0140] For detection, the detection device 7 may be designed to compare the acoustic signal 6 with one or more sound event patterns 17A, 17B.

[0141] The sound event patterns 17A, 17B can be presented as so-called audio samples, which have information about the sound events 5A, 5B. In this case, these are segments of the acoustic signal 6, which (in each case) have one or more sound events 5A, 5B that occurred in the past, were predicted, simulated or are suitable in another way for comparison with the signal 6. The sound event patterns 17A, 17B are in particular similar to the sound events for which the acoustic signal 6 is to be tested, or correspond to the latter. Alternatively or additionally, these are one or more sound events 5A, 5B representing information or information derived therefrom (such as processed, compressed or aggregated sound events). These include spectral and / or statistical information about the sound events.

[0142] The one or more sound event patterns 17A, 17B may have an assignment device. With these assignment devices, the assignment of the sound event patterns 17A, 17B or the sound events 5A, 5B corresponding thereto to the distribution device 3, the characteristics and / or state changes of the distribution device 3 or the substance 2 may be performed. The sound event patterns 17A, 17B or the assignment devices are therefore preferably designed for this purpose or contain information about the assignment. The assignment may be performed by the detection device 7. It is sufficient when the assignment devices are related, linked and / or (logically) associated with the corresponding sound event patterns 17A, 17B, so that the sound event patterns 17A, 17B have the assignment devices.

[0143] The detection device 7 preferably has one or more of the sound event patterns 17A, 17B. Alternatively or additionally, one or more of the sound event patterns 17A, 17B are stored in the database 13 and can be accessed from the database by the detection device 7.

[0144] The one or more sound event patterns 17A, 17B are used to detect corresponding sound events 5A, 5B in signal 6. To this end, detection device 7 compares sound event patterns 17A, 17B with signal 6. When a sound event 5A, 5B can be detected in signal 6 by means of sound event patterns 17A, 17B, this can be recorded as result 14.

[0145] When a plurality of sound events 5A, 5B are detected in the signal 6 by means of the same sound event pattern 17A, 17B, the latter may be recorded as one or more results 14 .

[0146] When a plurality of sound events 5A, 5B are detected in the signal 6 by means of a plurality of sound event patterns 17A, 17B, the latter may be recorded as one or more results 14 .

[0147] The result 14 can be output, further processed and / or transmitted by the detection device 7 via the output device 10 .

[0148] The detection device 7 preferably has a correlation module 16 for generating a correlation of the acoustic signal 6 with one or more sound event patterns 17A, 17B. The correlation can be done continuously and / or by mathematical folding in the time range or by multiplication in the frequency range, the latter preferably being based on a (Fourier) transform of the signal 6. The correlation is a preferred method for comparing the sound event patterns 17A, 17B with the signal 6.

[0149] The detection device 7 is preferably designed to output a result 14 when it is detected that the acoustic signal 6 is marked by a sequence of acoustic events 5A, 5B that succeed one another in time, the sequence corresponding to the progress of the steps of the dispensing process and the sequence therefore having corresponding acoustic events 5A, 5B. Alternatively or in addition, the detection device 7 is preferably designed to output an error when it is detected that the acoustic signal 6 is not marked by a sequence of acoustic events 5A, 5B that succeed one another in time, the sequence corresponding to the progress of the steps of the dispensing process and the sequence therefore having corresponding acoustic events 5A, 5B. In this way, the function and / or the drug can be advantageously ensured or improved with respect to reliability.

[0150] The detection device 7 preferably detects a dispensing process using the dispensing system 3 or by the substance 2. This can be performed by detecting the dispensing system 3 or by the substance 2 or based on this detection.

[0151] The detection device 7 can have a counter which counts the number of dispensing cycles or dispensing processes of the dispensing device 3 .

[0152] Alternatively or additionally, the detection device 7 is designed to compare the detected dispensing process with a preset value. Based on this, additional measures can optionally be automatically set, such as signaling or transmission of information.

[0153] Further processing of the results 14 can preferably be performed by the detection device 7 or externally, so that patient compliance (compliance / adherence) can be supported or controlled. To this end, information or warnings can be output based on one or more results 14. Alternatively or additionally, one or more results 14 or indicators derived therefrom can be forwarded, for example, to a medical practitioner, a medical system, etc.

[0154] Another aspect of the present invention which can also be implemented independently relates to the use of a mobile terminal device, preferably a smartphone, a tablet computer and / or a wearable device, in particular a smart watch or a fitness armband, as a detection device 7 or for detecting the dispensing of an administrable, preferably pharmaceutical substance 2 performed using a dispensing device 3, or for detecting a simulation of such a dispensing.

[0155] In this case, a mobile terminal device is used to pick up the sound signal 6 and test it for (characteristic) sound events 5A, 5B, which are generated by the dispensing device 3 during the preparation, execution or post-processing of the dispensing of the substance 2 and are specific to the dispensing device 3, the characteristics or state changes of the dispensing device 3 and / or the substance 2, or the dispensing process.

[0156] In an aspect that can also be implemented independently, the invention also relates to a computer program product with program code means which, when implemented, perform the method according to the proposed solution. In particular, the computer program product is a computer-readable (preferably non-volatile) storage medium with instructions which, when implemented on a processor 9, implement the method according to the proposed solution or an implementation of the steps of the method according to the proposed solution. This can be a storage device of the detection device, or a storage device separate therefrom.

[0157] The invention is explained based on a preferred example of a dispensing device 3 in the form of an automatic syringe. However, further dispensing systems 3, sound generators 4A, 4B and / or sound events 5A, 5B are possible, so that further examples based on FIGS. 4 to 7 are explained below.

[0158] FIG4 shows a secondary packaging 18. This is presented as a cover box in the example. The secondary packaging 18 can be separated by means of a tear tab 19 or along one or more predetermined score lines 20. In this case, the secondary packaging generates a sound event 5C. Thus, the tear tab 19 or the predetermined score line 20 forms a sound generator 4C.

[0159] The sound generator 4C is preferably designed to generate sound events 5C that are specific to or characteristic of the dispensing device 3 , a property or a change of state of the dispensing device or the substance 2 .

[0160] The specificity of the sound event 5C (ie its suitability for distinguishing the packaged dispensing device 3 from other dispensing devices 3) may be improved in that the sound generator 4C is changed / modified compared to a usual tear tab 19 or a predetermined score line 20.

[0161] Thus, specific or particular, preferably irregular, grooves or tooth shapes may be provided, for example grooves or tooth shapes at (especially periodic) variable distances of individual grooves or teeth or groups thereof, which, as indicated in the illustrative example, give rise to specific sound events 5C.

[0162] Fig. 5 shows a primary package 21 in which the dispensing device 3 is arranged directly. In the illustrated example, the primary package 21 is a blister with a receptacle 22 into which the dispensing device 3 is inserted and closed by means of a film 23 with a reversible edge-side adhesive 24 .

[0163] The membrane 23 can be pulled apart to be removed from the dispensing device 3. In this case, the membrane 23 forms a sound generator 4D. In this respect, the membrane 23 generates a specific noise as a sound event 5D during removal from the receptacle 22.

[0164] Typically, the structure of the sound generator 4D (here, i.e., the structure of the blister, the receptacle 22, the membrane 23 and / or the adhesive 24) is preferably designed so that during the process of generating the sound event 5D (here, tearing), the generation of the sound event 5D is variable, in such a way that the sound event 5D that can be generated or generated is or will be changed or modified accordingly throughout. In this way, the sound event 5D can be particularly specific or characteristic.

[0165] Alternatively or in addition, the sound event 5D can contain and transmit identification information. Thus, detection or differentiation can be performed in a particularly reliable manner with the aid of the identification information. In the case of other sound generators 4A-4D, corresponding measures are also possible. This can also be achieved by a sound generator 4A-4D that generates variable sound events 5A-5D, so that data is integrated into the sound event 5A-5D by variability or change, in particular modulation.

[0166] In the manner described and without limitation to a specific embodiment, the sound generators 4A-4D can thus be designed to acoustically modulate the identification information or other information in the sound events 5A-5D, preferably belonging to the dispensing device 3 and / or the substance 2. This causes a type of melody or chord progression or the evolution of various noises, by which the identification information or other information is converted by the structure of the sound generators 4A-4D into the sound events 5A-5D. In the example from FIG. 4 or otherwise in general, this can be performed by a tooth shape or topography that changes in the course of the tear tab 19 or the predetermined score line 20 or other surface structure 3E or counter structure 3F.

[0167] Based on the modulated sound events 5D, the detection device 7 can then enable detection or differentiation of the dispensing device 3 , a property or state change of the dispensing device 3 and / or the substance 2 , namely in particular in a reliable, specific and / or differentiated manner.

[0168] In this way, preferably by means of the detection device 7, the sound event patterns 17A, 17B can be compared with the acoustic signal 6, which corresponds to the sound event 5D with the modulation (identification) information. When the sound event 5D with the (identification) information is subsequently detected, the dispensing device 3, its characteristics, the change of state and / or the substance 2 is detected or will be detected or made possible.

[0169] Alternatively or additionally, multiple sound event patterns 17A, 17B may be provided for each modulated portion of sound event 5D and may be used to distinguish each modulated portion of sound event 5D. The result 14 or a series of results 14 may then be used to demodulate (identify) information.

[0170] The (identification) information can thus be recovered from the sound event 5D and can be used for a particularly reliable, individual and / or differentiated detection or differentiation of the dispensing device 3 , a property or state change of the dispensing device 3 and / or the substance 2 .

[0171] Preferably, the detection device 7 is correspondingly designed to demodulate the information modulated onto the sound event 5D in order to provide for an improved detection or differentiation of the dispensing device 3, a property or state change of the dispensing device 3 and / or the substance 2. To this end, the detection device 7 preferably has a demodulator for demodulating the acoustic signal 6 in order to recover the (identification) information modulated onto this signal 6 or into one or more sound events 5A-5D.

[0172] In another aspect, which can also be implemented independently, the dispensing device 3 can have a device 3G for changing the sound events 5A-D. In the illustrative example according to FIG. 5 , the device 3G is a gripping part or other device 3G applicable to the dispensing device 3 or its packaging. The device 3G can then be applied to the dispensing device 3. In particular, it can be plug-in.

[0173] The device 3G modifies the characteristics of one or more sound generators 4 of the dispensing device 3 in such a way that the one or more sound generators 4 generate sound events 5A-D that can be distinguished with and without the device 3G or with different devices 3G or designed for this purpose. In particular, the sound events 5A-D are modified in such a way that the natural resonant frequency or resonant element of the dispensing device 3 or the packaging, the damping characteristics or the general oscillation characteristics of the dispensing device 3 are changed.

[0174] By means of the device 3G for changing the sound events 5A-D, the sound events 5A-D can be individualized. In this way, the dispensing devices 3 can also subsequently be made distinguishable from one another. Thus, for example, by means of different devices 3G, otherwise identical dispensing systems 3 can be made distinguishable with respect to different substances 2.

[0175] FIG. 6 shows a sequence of sound events 5A-D in a signal 6 in three phases I, II and III which follow one another in time.

[0176] In the first phase I, the signal 6 in the first time span t1 has sound events 5C generated by the sound generator 4C of the secondary packaging 18 .

[0177] In phase II, after a rest time t2 for removing the primary package 21 , in a time span t3 , the signal 6 has a first sound event 5A which originates from the unlocking of the dispensing device 3 by means of the protective element 3D.

[0178] In phase III, after another rest time t4 of the movement of the dispensing system 3 to the dispensing point, in a time span t5, the signal 6 has a second sound event 5B originating from the sound generator 4B of the actuator 3C.

[0179] By testing the acoustic signal 6 for at least one sound event 5A-D, the signal can be checked by a detection device 7 for detecting or distinguishing the dispensing device 3 , a property or state change of the dispensing device 3 , and / or the substance 2 .

[0180] Thus, the check may be limited to the second sound event 5B detected in phase III. This sound event 5B may be specific or characteristic, in particular sufficient to detect the dispensing device 3 as belonging to a group and / or to detect the dispensing of a substance 2 using this dispensing device 3 .

[0181] Alternatively, the signal 6 may be checked for at least two sound events 5A-D. When the check is performed for the first sound event 5A and the second sound event 5B and both sound events 5A, 5B in phases II and III are checked, then in addition to the finding from detecting only the second sound event 5B, it can be detected that the dispensing device 3 is ready (i.e., by removing the protective component 3D) for dispensing.

[0182] When performing a check on the sound events 5C originating from the sound generator 4C of the secondary packaging, it is alternatively or additionally possible to detect whether the dispensing system 3 has been removed from the secondary packaging 18 as intended.

[0183] When performing a check on the sound events 5D originating from the sound generator 4D of the primary package 21, it may alternatively or additionally be detected whether the dispensing system 3 has been removed from the primary package 21 as intended. This is not the case in the described example.

[0184] The signal 6 is preferably checked for at least two, particularly preferably at least or exactly three sound events 5A, 5B, 5C / 5D (i.e. unpacking, unlocking and triggering). Thus, when all sound events 5A, 5B, 5C / 5D in the signal 6 are detected (by the detection device 7), it can be inferred that the dispensing device 3 of a properly prepared initial package has been triggered and that a direct dispensing (optionally, which substance 2 was dispensed) has taken place.

[0185] Preferably, a series of sound events 5A-5D is checked (by means of the detection device 7). Furthermore, it can thus be detected (by means of the detection device 7) whether a distribution process is completed in a planned series.

[0186] Alternatively or additionally, as explained above, the dispensing device 3 , a property or state change of the dispensing device 3 and / or the substance 2 may be identified.

[0187] In another example, FIG. 7 shows a dispensing device 3 in the form of a cylinder having a sound generator 4E in the form of an accessory device 25 which, in the schematic example, can be inserted into the dispensing device 3 or can be applied to the dispensing device in some other way, preferably in a reversible manner.

[0188] The sound generator 4 is here formed by a spring arm 26 in combination with a groove of the closure of the dispensing device 3. The spring arm generates a specific or characteristic click as a sound event 5E when the dispensing device 3 is opened. The groove can be designed to modulate the sound event 5E.

[0189] However, in addition to the depicted examples, various additional dispensing devices 3, sound generators 4A-4E and / or sound events 5A-5E are possible.

[0190] In one aspect of the invention, the sound generators 4A-4E generate sound events 5A-5D or are designed for this purpose, which correspond to a manufacturer or are specific to a manufacturer. Therefore, the corresponding sound event patterns 17A, 17B preferably have assignment means, which identify or assign the manufacturer. In this way, the dispensing device 3 or the substance 2 can be manufacturer-identified. Moreover, in any case, the affiliation of the dispensing device 3 or the substance 2 with the manufacturer can be detected. This information can be used to verify or exclude the detection of the dispensing system 3 as a whole.

[0191] In one aspect of the invention, the sound generators 4A-4E generate sound events 5A-5D or are designed for this purpose, which correspond to or are specific for the active ingredient concentration. Therefore, the sound event patterns 17A, 17B corresponding to the sound events 4A-4E preferably have an assignment device, which enables the identification or assignment of the active ingredient concentration. In this way, the active ingredient concentration of the substance 2 can be detected. On this basis, in particular together with the counting results, the drug compliance can then be determined.

[0192] In another aspect of the invention, the detection or differentiation of the one or more dispensing devices 3 and / or the one or more substances 2 is counted, or the detection device 7 is designed for this purpose. In particular, the direct distribution of the substance 2, the distribution process or the direct distribution using a determined or certain type of one or more dispensing devices 3 is counted. The result is referred to as the counting result. In this case, this can be a count or an amount or a size without reference or with a time reference, such as a detection or differentiation or a distribution process for each time span or (average) time span between the distribution processes.

[0193] In another aspect of the invention, the detection device 7 is designed to generate and store one or more results 14 or information derived therefrom for drug compliance in a database and / or on an application device for automatic dispensing or automatic dispensing of an adapted substance 2, or forwarding to other substances 2. This can but need not be done based on counting or counting results.

[0194] In another aspect of the present invention, the sound generator 4A-4E is an electroacoustic transducer (such as a piezoelectric element, a speaker, etc.), or has such an electroacoustic transducer. The electroacoustic transducer can be excited and / or activated in a step of the distribution process or can be excited and / or activated by a step of the distribution process for a reason, so as to generate a specific (if necessary, complex) sound event 5A-5E. In particular, the electroacoustic transducer can also be used to reliably modulate complex data or data packets in the sound event 5A-5E.

[0195] In another aspect of the invention, the sound generator 4A-4E is a piezoelectric element or other element for generating ultrasound, or has such an element. Sound events 5A-5E in the ultrasonic range make detection based on the basic specificity of such sound events 5A-5E possible, or facilitate detection based on the basic specificity of such sound events. Unlike sound events 5A-5E, ultrasound is less often generated by incidents in the audible range and is contained in the ambient noise at a lower amplitude, thus facilitating detection.

[0196] In another aspect of the invention, the dispensing device 3 has a housing part as a sound generator 4A-4E, which is preferably adaptable or specially designed for sound generation or amplification.

[0197] In another aspect of the present invention, the sound generator 4 has one or more elastic elements, such as pins, spring arms, elastic structures or spring-loaded structures. The elastic elements are preferably designed by interaction with another part for generating sound events 5A-5E. Specifically, they interact with the surface structure 3E or the opposing structure 3F during the distribution process to form sound events 5A-5E. For example, one or more elastic elements are arranged in or on the cap, or are generally arranged in or on the closure for supplying a receiving seat (especially a medicine reservoir).

[0198] In another aspect of the invention, a blister is provided as a sound generator 4A-4E. For example, the latter can generate sound events 5A-5E (eg, corresponding to active ingredient concentration, etc.) by a modified blister membrane or system coupled to the blister with the contents of the blister removed.

[0199] In another aspect of the invention, the sound events 5A-5E are used to identify a specific stage or a specific sequence of events in the dispensing process.

[0200] In other aspects of the invention, the detection device 7 is particularly designed to detect one or more of the described specific sound events 5A-5E. To this end, the detection device 7 can use the corresponding specific sound event patterns 17A, 17B. Preferably, based on the sound event patterns 17A, 17B, the detection device 7 automatically assigns corresponding information belonging to the things specified by the sound events 5A-5E. Alternatively or additionally, the detection device 7 can have a microphone that converts a specific frequency range, in particular audible frequencies and / or ultrasound, into an electric current or voltage.

[0201] In other aspects of the invention, the sound generator 4A-4E generates a continuous, preferably constant or single-frequency sound wave. In this case, the sound event 5A-5E may include modifying this sound wave, especially with respect to frequency and / or amplitude.

[0202] In the following, a third embodiment of the dispensing device 3 according to the proposed solution will be discussed with particular reference to Figures 8A to 13. All previous explanations concerning the system 1 and the dispensing device 3 also apply to the third embodiment of the dispensing device 3, if not otherwise indicated or obvious from the context.

[0203] The dispensing device preferably has a longitudinal axis or main axis A. Terms relating to an axis (such as "axial", "radial", etc.) preferably relate to the axis A. For example, an "axial" direction or movement is a direction or movement parallel to the axis A, while a "radial" direction or movement is a direction or movement radial to the axis A.

[0204] The dispensing device 3 according to the third embodiment is preferably configured substantially the same as the dispensing device 3 according to the first embodiment shown in Figures 2A to 2B. The dispensing device 3 according to the third embodiment preferably differs from the dispensing device 3 according to the first embodiment only in the configuration of the protection element 3D.

[0205] The dispensing device 3 preferably has a body 3H and a protective element 3D.

[0206] The protective element 3D preferably forms a lid and / or a cover of the dispensing device 3, in particular for covering the axial ends of the body 3H. Particularly preferably, the protective element 3D is or forms a cap.

[0207] The protection element 3D is preferably detachable from and / or attachable to the body 3H. Preferably, the protection element 3D can be or is reversibly retained on the body 3H, in particular at its axial ends, preferably by a latching and / or snapping mechanism.

[0208] The protection element 3D may be covered by an additional cap or cover not shown in the drawings.

[0209] The protection element 3D and / or the dispensing device 7 are preferably designed as a single-use and / or disposable product.

[0210] The protection element 3D preferably has or forms a sound generator 4A. The sound generator 4A of the dispensing device 3 according to the third embodiment is preferably similar to the sound generator 4A of the dispensing device 3 according to the first embodiment, wherein the differences will be described below.

[0211] Preferably, all parts of the sound generator 4A are comprised by and / or integrated in the protective element 3D. The protective element 3D preferably completely comprises the sound generator 4A. The body 3H preferably does not comprise the sound generator 4A or parts thereof.

[0212] The sound generator 4A is designed to generate at least one reproducible sound event 5A in the acoustic signal 6 in preparation for actual or simulated dispensing of the substance 2 , the sound event 5A being specific for a property and / or a state change of the dispensing device 3 .

[0213] The protection element 3D is preferably configured to keep the substance 2 from being dispensed in an initial state of the dispensing device 3. The dispensing device 3 may preferably be transferred to an activated state initiating dispensing of the substance 2, wherein a sound event 5A is generated when transferring the dispensing device 3 to the activated state.

[0214] Different states of the dispensing device 3 are shown in Figures 8A to 8C. Figure 8A depicts an initial state, Figure 8C depicts a start-up state, and Figure 8B depicts an intermediate state adopted when transferring the dispensing device 3 from the initial state to the start-up state.

[0215] The initial state is in particular a state in which the protective element 3D (in particular a cap) is attached to the body 3H of the dispensing device 3 and thus covers the body 3H and / or prevents the dispensing of the substance 2. The start state is in particular a state in which the protective element 3D or the cap has been removed from the body 3H and thus the dispensing of the substance 2 is started.

[0216] The protection element 3D and / or the dispensing device 3 are preferably configured to generate a sound event 5A when the protection element 3D and / or the dispensing device 3 are transferred from the initial state to the activation state. Specifically, the protection element 3D and / or the dispensing device 3 are configured to generate a sound event 5A when the protection element 3D is removed from the body 3H.

[0217] The generated sound event 5A is preferably independent of the speed, force and / or other external parameters used to transform the protective element 3D or the dispensing device 3 to the activated state, in particular to remove the protective element 3D from the body 3H. In other words, the generated sound event 5A does not depend on the way in which the user (not shown) removes the protective element 3D or the cap from the body 3H, but the generated sound event 5A is always the same, regardless of whether, for example, the user removes the protective element 3D slowly or quickly. This is achieved in particular by the construction of the protective element 3D and / or the internal mechanism of the protective element 3D having or forming the sound generator 4A and contributes to the reproducible generation of the sound event 5A.

[0218] The protection element 3D can preferably be positioned in different positions, as can be seen from Figures 8A-8C. In particular, the protection element 3D has an activated position.

[0219] The protective element 3D is preferably configured to automatically, immediately and / or necessarily generate a sound event 5A after reaching the activation position, specifically, wherein the generated sound event 5A is independent of the manner in which the protective element 3D is manipulated (e.g., whether the protective element 3D is slowly or quickly removed from the body 3H).

[0220] Preferably, only when the protection element 3D is positioned in the activation position (before the generation of the sound event 5A), the sound event 5A can be generated. In other words, positioning the protection element 3D in the activation position is preferably a necessary condition, without which the sound event 5A cannot be generated.

[0221] The activation position is preferably a position that must be reached to initiate the generation of sound event 5A. Preferably, the activation position is a defined position of the protection element 3D that is defined or determined by the construction of the protection element 3D.

[0222] The "manipulation" of the protection element 3D and / or the dispensing device 3 is preferably any action (especially by a user) by which the position and / or the state of the protection element 3D and / or the dispensing device 3 is changed. In particular, the manipulation of the protection element 3D includes or means the process of removing the protection element 3D from the body 3H and / or moving different parts of the protection element 3D relative to each other.

[0223] The protective element 3D preferably has a drive element 27. The drive element 27 is preferably a spring, in particular a tension spring. Preferably, the drive element 27 is arranged, in particular completely, in the protective element 3D or on its inner side.

[0224] The drive element 27 is preferably configured to be activated, in particular stretched, by manipulating the protection element 3D so as to reach the activated position, in particular by positioning or moving the protection element 3D towards or in the actuated position.

[0225] Further, drive element 27 is preferably configured to automatically, immediately and / or necessarily cause the generation of sound event 5A after protection element 3D has reached the activation position.

[0226] The protective element 3D preferably has a first part 28 and a second part 29. The first part 28 is preferably configured as a cap, and the second part 29 is preferably configured as a sleeve, which is particularly arranged or can be arranged in the cap, in particular coaxially with the cap. Specifically, the first part 28 and the second part 29 are at least substantially cylindrical.

[0227] The first and second parts 28, 29 are movable relative to each other between an initial position and an activated position. The terms "initial position" and "activated position" denote different positions of the protection element 3D, and thus in particular different positions of the first and second parts 28, 29 relative to each other.

[0228] The initial position of the protection element 3D is depicted in FIGS. 11A and 12A , and the activated position is depicted in FIGS. 11B and 12B .

[0229] In the initial position, the second part 29 is preferably fully inserted into the first part 28. The initial position is preferably a rest position in which the protection element 3D is held or pre-tensioned and / or into which the protection element 3D returns when no external force acts on the protection element 3D and / or drives the parts 28, 29 apart or prevents the parts 28, 29 from moving relative to each other.

[0230] The activation position is particularly a position in which the first part 28 and the second part 29 have moved relative to each other about the initial position, particularly moved apart. In the illustrative example, the activation position is a position in which the second part 29 has (partially) moved out of the first part 28 and / or extended beyond the first part 28.

[0231] The initial position and the activated position are preferably different axial and / or rotational positions of the first part 28 and the second part 29 relative to each other.

[0232] The activation position is preferably defined or determined by the construction or configuration of the first portion 28 and the second portion 29, as explained in more detail below.

[0233] Note that the "initial state" of the dispensing device 3 and the "initial position" of the protection element 3D are different, but distinct from each other. In FIG. 8A , the protection element 3D is shown in the initial position, and the dispensing device 3 is shown in the initial state. However, in FIG. 8B , the first portion 28 and the second portion 29 of the protection element 3D have been moved relative to each other, so that the protection element 3D is not in the initial position. In FIG. 8C , the protection element 3D is again in the initial position (as described later), while the protection element 3D has been completely removed from the body 3H, and the dispensing device 3 is therefore in the activated state.

[0234] The driving element 27 is configured to hold and / or pre-stretch the protection element 3D or the first part 28 and the second part 29 in an initial position. The driving element 27 is preferably configured to be stretched by moving the first sound part 28 and the second sound part 29 apart. Preferably, the driving element 27 is arranged and / or stretched between the first part 28 and the second part 29. Further preferably, the driving element 27 is engaged with the first part 28 and / or the second part 29, and / or attached to the first part and / or the second part.

[0235] The first part 28 and the second part 29 are preferably linearly movable relative to each other. As an alternative or in addition, the first part 28 and the second part 29 are at least rotatable relative to each other to a certain extent and / or within a certain range. In the example shown, the first part 28 and the second part 29 are both linearly movable and rotatable relative to each other within a limited range, as explained in more detail below.

[0236] The second part 29 preferably has several elements or is formed by several elements, in particular a sleeve element 29A and a mating element 29B. In principle, the second part 29 can also be formed by only one piece. However, a two-piece construction with a sleeve element 29A and a mating element 29B has proven to be advantageous for manufacturing and assembling the protective element 3D or the second part 29.

[0237] The sleeve element 29A is preferably configured as a sleeve and / or substantially cylindrical. The mating element 29B is preferably inserted into the sleeve element 29A and / or arranged coaxially with the sleeve element. Specifically, the sleeve element 29A has a recess configured to receive or retain the mating element 29B.

[0238] The sleeve element 29A and the matching element 29B preferably form a unit, in particular wherein the sleeve element 29A and the matching element 29B are immovable relative to each other and / or do not move relative to each other during use of the dispensing device 3 and / or the protective element 3D. In other words, the sleeve element 29A and the matching element 29B are preferably in a fixed position relative to each other. This can be achieved, for example, by fixedly attaching the sleeve element 29A and the matching element 29B to each other (e.g., by a latch mechanism) and / or by providing a permanent connection between the sleeve element 29A and the matching element 29B (e.g., by gluing, welding, etc.).

[0239] The protection element 3D preferably has a latch mechanism and / or a stopper for preventing the second part 29 from being detached or removed from the first part 28 and / or for preventing the first part 28 and the second part 29 from relative movement beyond an activated position.

[0240] The latching mechanism or stopper preferably has a claw or an engagement hook 30 or is formed by the claw or the engagement hook, which is particularly arranged on the first part 28 and an engagement element 31 corresponding to the engagement hook 30 or configured to engage with the engagement hook, preferably, wherein the engagement element 31 is arranged on the second part 29, in particular on the mating element 29B.

[0241] The claw or engagement hook 30 is preferably formed by a flexible arm, which is arranged and / or cut out, in particular, from the cylindrical and / or peripheral wall of the first part 28. The engagement element 31 is preferably formed by a radially protruding element of the second part 29 or the mating element 29B, which is in particular arranged on an axial end of the second part 29 or the mating element 29B.

[0242] Particularly preferably, the latching mechanism or the catch has or is formed by two engagement hooks 30 and two engagement elements 31 , which are each arranged on radially opposite sides of the first part 28 or the second part 29 .

[0243] The latching mechanism or stop can be configured to reversibly retain the second part 29 or to irreversibly or inseparably connect the second part 29 to the first part 28 so that the second part 29 cannot be removed or disassembled from the first part 28 (without destroying the protective element 3D, i.e., the first part 28 and / or the second part 29).

[0244] The sound generator 4A is preferably configured to generate the sound event 5A purely mechanically. In particular, the sound generator 4A and / or the protection element 3D comprises a first sound generating element 32A and a second sound generating element 32B configured to (reproducibly) generate the sound event 5A.

[0245] In particular, the sound generator 4A is a ratchet, and / or the sound event 5A is generated by the sound generating elements 32A, 32B by moving the sound generating elements 32A, 32B relative to each other. Preferably, the first sound generating element 32A comprises a rib surface structure or a corrugated surface structure. The corresponding second sound generating element 32B preferably has a protrusion or is formed by a protrusion. By moving the protrusion on the rib structure or the corrugated structure, a ratchet sound is generated.

[0246] Preferably, the first part 28 has or forms a first sound generating element 32A, and the second part 29 has or forms a second sound generating element 32B. The first sound generating element 32A is preferably arranged on the inner wall of the first part 28, and the second sound generating element 32B is preferably arranged on the outer wall of the second part 29 (specifically the sleeve element 29A).

[0247] The first sound generating element 32A is preferably attachable to, detachable from and / or replaceable from the first part 28. Preferably, the first sound generating element 32A is reversibly retained or retainable on the first part 28, for example by a latching mechanism or the like. In this way, different protective elements 3D and / or dispensing devices 3 can be equipped with different sound generating elements 32A or different sound generators 4A, so that the sound generator 4A can be adapted to the substance 2 of the dispensing device 3 and so that the sound event 5A is specific to the substance 2.

[0248] Preferably, the sound generator 4A has or is formed by two identical pairs of corresponding sound generating elements 32A, 32B.

[0249] After the protection element 3D is moved from the initial position to the activated position and / or when the protection element 3D returns from the activated position to the initial position, the protection element 3D and / or the sound generator 4A are preferably configured to preferably only and / or exclusively generate the sound event 5A.

[0250] Note that, accordingly, expressions such as "returning from the activated position to the initial position" or "moving from the activated position to the initial position" do not necessarily mean that the protection element 3D is actually in the initial position again at the end of the return or movement. In other words, it is not necessary to reach the initial position again, but it is sufficient to return or move substantially towards the initial position or in the direction of the initial position (in particular at least substantially opposite to the movement from the initial position to the activated position), even if the protection element 3D does not end up in the initial position. Therefore, a movement from the activated position that does not reach the initial position or does not end in the initial position is preferably also included in the expression "returning from the activated position to the initial position" or "moving from the activated position to the initial position" or the like.

[0251] In the illustrative example, reaching the initial position at the end of returning from the activation position requires or includes rotating back to the initial position, as explained in more detail below. In particular, such a rotation that preferably occurs after the generation of the sound event 5A can be omitted.

[0252] The protection element 3D is depicted in an initial position in FIGS. 11A and 12A , and in an activated position in FIGS. 11B and 12B .

[0253] The protective element 3D or the parts 28, 29 are preferably movable or moveable from the initial position to the activated position by, in particular, axially moving apart the first and second parts 28, 29. Moving apart the first and second parts 28, 29 preferably occurs automatically during the removal of the protective element 3D from the body 3H, as in particular depicted in FIGS. 8A and 8B .

[0254] The "removal process" of the protection element 3D is in particular a process by which or at the end of which the protection element 3D is removed from the body 3H. The process of removing the protection element 3D preferably includes several positions of the protection element 3D and / or states of the dispensing device 3. The actual removal of the protection element 3D from the body 3H preferably only takes place at the end and / or final step of the process, as will become clearer below.

[0255] The dispensing device 3 is preferably configured to move the protection element 3D into the activated position during removal of the protection element 3D and / or the first portion 28 from the body 3H.

[0256] Specifically, the dispensing device 3 or the main body 3H (in particular, the preferably at least substantially cylindrical needle guard 34 arranged in the main body 3H and / or (radially) around the injection needle 3B) is configured to hold the second part 29 in a fixed position relative to the main body 3H during the process of removing the protective element 3D and / or the first part 28 from the main body 3H, and to move the protective element 3D from the initial position to the activated position by moving the first part 28 relative to the second part 29 and / or the main body 3H (in particular, moving the first part 28 away from the main body 3H).

[0257] Therefore, the process of removing the protection element 3D from the body 3H preferably comprises steps in which the first portion 28 has moved away from the body 3H, while the second portion 29 has not yet moved relative to the body 3H. This is particularly shown in Figure 8B.

[0258] The dispensing device 3 preferably has a pawl 33 for engaging with the protective element 3D, in particular the second part 29, particularly preferably the mating element 29B. The pawl 33 is preferably configured to hold the second part 29 at least temporarily in a fixed position relative to the body 3H during the process of removing the protective element 3D from the body 3H.

[0259] The pawl 33 is preferably arranged on a flexible arm, which is particularly arranged on an inner wall of the body 3H, particularly in the needle guard 34 .

[0260] The second portion 29, in particular the mating element 29B, preferably has an undercut 35 for engaging with the pawl 33. The undercut 35 is preferably configured as a notch, which in particular extends circumferentially around the second portion 29 or the mating element 29B.

[0261] The pawl 33 and / or the flexible arm are preferably configured to release the second part 29 from the pawl 33 when the protective element 3D and / or the first part 28 have reached the activated position and the protective element 3D and / or the first part 28 (subsequently) move further away from the body 3H. The force with which the second part 29 is held by the stopper or the engagement hook 30 is preferably greater than the force with which the second part 29 is held by the pawl 33, so that when the protective element 3D is already in the activated position and then moves further away from the body 3H, the engagement between the pawl 33 and the second part 29 is released.

[0262] Preferably, the drive element 27 is configured to be activated, in particular stretched, when the protection element 3D or the portion 28, 29 is moved from the initial position to the activated position.

[0263] The protection element 3D is preferably configured to return to the initial position when or after the protection element 3D has moved from the initial position to the activated position. However, as explained above, returning to the initial position is not necessary. Preferably, the sound event 5A is generated after the activation position has been reached and / or during the movement or return (in particular to the initial position) of the protection element 3D or the parts 28, 29.

[0264] The movement from the activated position to the initial position preferably occurs automatically and / or immediately after the activated position has been reached. Specifically, the drive element 27 is configured to drive the protection element 3D back from the activated position to the initial position. As explained before, the drive element 27 is preferably activated or stretched by moving from the initial position into the activated position, so that the return from the activated position to the initial position is caused or driven by the elastic restoring force of the stretched spring or drive element 27. In other words, the movement from the activated position to the initial position preferably occurs purely mechanically.

[0265] The protection element 3D is preferably configured so that no sound or sound event 5A is generated when the protection element 3D moves from the initial position to the activated position, and / or the sound event 5A is generated (only) after the movement from the initial position to the activated position, in particular when the protection element 3D moves from the activated position to the initial position. In other words, the protection element 3D and / or the sound generator 4A are preferably configured so that the sound generating elements 32A, 32B do not interact or contact each other when moving from the initial position to the activated position, and / or the sound generating elements 32A, 32B interact or contact each other (only) after the movement from the initial position to the activated position, in particular when moving from the activated position to the initial position, so that the sound event 5A is generated.

[0266] The non-interaction of the sound generating elements 32A, 32B when moving from the initial position toward the activated position also contributes to the easy operation of the dispensing device, in particular for the smooth removal of the protective element 3D from the body 3H. That is, when removing the protective element 3D from the body 3H, a considerable force is already required to resist the spring tension of the drive element 27, which force will be further increased by the interaction of the sound generating elements 32A, 32B when moving from the initial position toward the activated position. Therefore, the non-interaction of the sound generating elements 32A, 32B is advantageous for easy operation, in particular for keeping the force required to remove the protective element 3D at an acceptable level.

[0267] The protection element 3D preferably has a guide configured so that the sound generating elements 32A and 32B do not interact with each other when the protection element 3D moves from the initial position to the activation position, and so that the sound generating elements 32A and 32B interact with each other and generate sound event 5A when the protection element 3D moves from the activation position to the initial position.

[0268] The guide is preferably configured to rotate the second part 29 when reaching the activation position and / or (immediately) after reaching the activation position. Thus, when moving from the initial position to the activation position, the second part 29 is preferably arranged in a different rotational position relative to the first part 28 than when moving from the activation position back to the initial position. By rotating, it is in particular achieved that the sound generating elements 32A, 32B do not interact or contact each other when moving from the initial position to the activation position and / or that the sound generating elements 32A, 32B (only) interact or contact each other when moving from the activation position to the initial position and thus generate a sound event 5A.

[0269] The guide is preferably configured to ensure that the sound event 5A is generated only after the activation position has been reached.

[0270] The guide preferably has or is formed by several guide elements, in particular a first guide element 36A, a second guide element 36B, a third guide element 36C and / or a fourth guide element 36D.

[0271] The first, second, third and / or fourth guide elements 36A- 36D are preferably (each) configured as a protrusion or a projection.

[0272] Preferably, the protection element 3D comprises two identical guides arranged on radially opposite sides of the protection element 3D.

[0273] The first part 28 preferably has a first guide element 36A. The first guide element 36A is preferably arranged on and / or protrudes from a (especially cylindrical) inner wall of the first part 28, as shown in particular in Fig. 10. Preferably, the first guide element 36A extends axially and / or is elongated.

[0274] The first guide element 36A is preferably at least substantially in the form of a quadrilateral, wherein two sides of the guide element 36A extend parallel to the axis A and the other two sides are inclined relative to the axis A. Particularly preferably, the first guide element 36A is at least substantially in the form of a parallelogram.

[0275] The second part 29 preferably has a second, third, fourth and / or fifth guide element. The second, third and / or fourth guide element 36B-36D is preferably arranged on and / or protrudes from the (especially cylindrical) outer wall of the second part 29, as shown in particular in FIG.

[0276] The second guide element 36B is preferably configured to contact and / or slide along the first guide element 36A.

[0277] The second guide element 36B is preferably at least substantially in the form of a quadrilateral. The second guide element 36B preferably has two slides extending parallel to the axis A and two slides inclined relative to the axis L. Particularly preferably, the first guide element 36A is in the form of a parallelogram or a rhombus.

[0278] The second guide element 36B is preferably configured to extend around the first guide element 36A when the protection element 3D is moved from the initial position to the activated position and returned to the initial position.

[0279] The second guide element 36B is preferably arranged at the free end of a flexible arm 37 of the second portion 29. The arm 37 is preferably configured to deflect at least substantially circumferentially when the protective element 3D moves from the initial position to the activated position, and / or to flip back before and / or when the protective element 3D moves from the activated position to the initial position.

[0280] The arm 37 is preferably formed in one piece with the second portion 29, in particular the sleeve element 29A. Specifically, the arm 37 is formed by an axial cutout of the cylindrical wall of the sleeve element 29A.

[0281] The fourth guide element 36D is preferably configured as an axially extending track. The fourth guide element 36D is preferably configured to limit the rotation of the second part 29 relative to the first part 28 , in particular by contacting the engagement hook 30 .

[0282] The function of the guide is explained below with specific reference to FIGS. 11A to 13 .

[0283] In Figures 11A and 12A, the protection element 3D is shown in an initial position. In Figures 11B and 12B, the protection element 3D is shown in an activated position. Figure 13 shows a bottom view of the protection element 3D in the initial position.

[0284] In the initial position, the sound generating elements 32A, 32B are offset from each other in the circumferential direction, as can be seen in particular in Fig. 13. Further, the engagement hook 30 is in contact with the fourth guide element 36D, preferably such that the second part 29 is prevented from rotating in the clockwise direction in Fig. 13 .

[0285] As can be seen in FIGS. 12A and 13 , the first guide element 36A and the second guide element 36B overlap in the axial direction such that the inclined sides of the first guide element 36A and the second guide element 36B contact when the protection element 3D moves from the initial position toward the activated position.

[0286] Since the rotation of the second part 29 in the clockwise direction in Figure 13 is prevented by the engaging hook 30 and the guide elements 36A and 36B overlap in the axial direction, when the guide elements 36A and 36B are in contact, when the protective element 3D moves further toward the activated position, the flexible arm 37 having the second guide element 36B is forced to bend or deflect (especially in the circumferential direction).

[0287] The deflection of the arm 37 preferably builds up a restoring force in the arm 37 and / or presses the second guide element 36B (particularly an axial side thereof) against the first guide element 36A (particularly an axial side thereof).

[0288] When the first part 28 and the second part 29 are further moved apart, the activation position is reached. The activation position is in particular a position where the second guide element 36B has reached the axial end of the first guide element 36A, as shown in particular in FIG. 12B . Specifically, the activation position is a reversal point and / or position of the protection element 3D, wherein the second part 29 is caused to rotate and / or move or slide back to the initial position at a different rotational position than the path from the initial position to the activation position and / or along a different path and / or on a different axial side of the first guide element 36A.

[0289] In the activated position, the engagement hook 30 is preferably engaged with the engagement element 31 .

[0290] When or immediately after reaching the activation position, the restoring force of the bent or deflected arm 37 preferably causes the arm 37 to move or flip back to its rest position, i.e., a position in which the arm 37 is in the initial position of the protective element 3D. In this way, the second guide element 36B moves relative to the first guide element 36A, in particular so that the second guide element 36B passes a corner at the end of the first guide element 36A, and / or the inclined edges of the guide elements 36A, 36B contact each other.

[0291] The spring or drive element 27 is preferably stretched when the protection element 3D moves from the initial position to the activated position, as shown in FIGS. 11A and 11B .

[0292] Therefore, the drive element 27 preferably causes or drives the second part 29 to move back towards the initial position when or immediately after having reached or passed the activation position.

[0293] When returning from the activated position to the initial position, the second guide element 36B preferably slides along the first guide element 36A, in particular on the axial side opposite to the axial side along which the second guide element 36B has slid when moving from the initial position to the activated position.

[0294] When moving from the activated position to the initial position, the movement of the second guide element 36B along the first guide element 36A preferably involves a rotation of the second part 29 relative to the first part 28, in particular in the counterclockwise direction in Figure 13. This is particularly affected by the inclined edge of the first guide element 36A and the circumferential movement of the second guide element 36B caused thereby. By this rotation, the rotational position of the first part 28 and the second part 29 relative to each other is changed in such a way that the sound generating elements 32A, 32B of the sound generator 4A interact when moving from the activated position to the initial position and generate a sound event 5A.

[0295] The third guide element 36C is preferably inclined relative to the axis A and / or the first guide element 36A so that towards the end of the movement from the activation position to the initial position, the rotation of the second part 29 back into the initial position is achieved by interaction between the first guide element 36A and the third guide element 36C.

[0296] In summary, removing the protective element 3D from the body 3H and / or generating the sound event 5A is preferably performed as follows:

[0297] At the beginning, the protective element 3D, in particular in the form of a cap, is attached to the body 3H. In this position, the protective element 3D is in an initial position and the pawl 33 engages the second portion 29.

[0298] In order to remove the protection element 3D from the body 3H, a user (not shown) pulls the first part 28 away from the body 3H, particularly in the axial direction. In this way, the first part 28 and the second part 29 move relative to each other, while the second part 29 is held by the pawl 33 and therefore does not move relative to the body 3H. By the relative movement of the first part 28 and the second part 29, the drive element 27 is preferably stretched.

[0299] During this movement, the second guide element 36B preferably slides along the first guide element 36A, in particular wherein the flexible arm 37 is deflected circumferentially or upwardly, in particular in FIGS. 11A to 12B .

[0300] The user preferably moves the first portion 28 away from the body 3H until the activated position is reached.

[0301] When reaching or passing the activated position, the arm 37 preferably flips back so that the second guide element 36B moves around the first guide element 36A and / or on the opposite side of the guide element 36A (the underside of the guide element 36A in FIGS. 12A and 12B ).

[0302] Further, when or shortly after reaching the activation position, the second portion 29 is released from the pawl 33. This results in a rapid movement of the protection element 3D towards the initial position, in particular driven by the drive element 27.

[0303] Furthermore, the second part 29 has been rotated in the counterclockwise direction in Figure 13 when reaching or passing the activation position, in particular by flipping back through the arm 37. By this rotation, the second part 29 is brought into a rotational position relative to the first part 28, which enables the interaction of the sound generating elements 32A, 32B.

[0304] By rapidly moving from the activated position to the initial position, a sound event 5A is generated by the sound generating elements 32A, 32B sliding along each other.

[0305] Towards the end of the movement back to the initial position, the third guide element 36C preferably contacts the first guide element 36A and thereby causes the second portion 29 to rotate back to the initial position (in particular clockwise in FIG. 13 ). However, this is not mandatory.

[0306] The protection element 3D (in particular the guide) may also have a fastening device for preventing contact and / or interaction between the sound generating elements 32A, 32B when moving from the initial position to the activated position, for example, corresponding guide elements, stops, latch elements, etc. Specifically, the fastening device is configured to prevent the second part 29 from rotating relative to the first part 28 (in particular in the counterclockwise direction in FIG. 13) when moving from the initial position to the activated position. Preferably, a fastening element is provided to ensure that the second guide element 36B slides along the correct side of the first guide element 36A as described above when moving from the initial position to the activated position. In this way, incorrect operation by the user can be prevented. Specifically, it is possible to prevent the parts 28, 29 from rotating relative to each other when the protection element 3D is removed from the body 3H, which may occur when the protection element 3D is slightly twisted at the beginning of the movement from the initial position to the activated position.

[0307] The fastening device is preferably arranged on the first and / or second part 28, 29. Preferably, the fastening device is configured to contact one of the guide elements 36A-36D, in particular the first guide element 36A or the fourth guide element 36D, at least in said initial position and / or when moving from the initial position to the activated position.

[0308] The protection element 3D preferably has a damping device for controlling, damping and / or reducing the speed and / or acceleration of the movement of the protection element 3D from the activated position to the initial position.

[0309] The damping device may for example be realized by reinforcing parts of the protection element 3D, in particular the sound generating elements 32A, 32B, such that the pressure with which the sound generating elements 32A, 32B press against each other is increased.

[0310] Other possible solutions are pneumatically broken cylinder-piston arrangements that damp the air escaping from the protective element 3D and / or regulate the damping of the movement from the activated position to the initial position.

[0311] As an alternative or in addition, it is also conceivable to vary the exact design of the sound generating element and / or the spring force (eg of the drive element 27 and / or the flexible arm 37) and / or to provide additional springs or tensioning devices.

[0312] Another embodiment of a protection element 3D and / or a sound generator 4A is shown in FIG. 14 .

[0313] The sound generator 4A of the protective element 3D according to FIGS. 8A to 13 preferably operates purely mechanically, whereas the sound generator 4A of the embodiment shown in FIG. 14 preferably operates electronically.

[0314] The explanations concerning the protection element 3 according to the embodiment shown in FIGS. 8A to 13 preferably also apply to the protection element according to the embodiment shown in FIG. 14 , unless otherwise indicated or obvious from the context.

[0315] In particular, the protective element 3D forms a lid and / or a cover, in particular in the form of a cap, of the dispensing device 3. Further, the protective element 3D preferably has or forms a sound generator 4A.

[0316] The protective element 3D preferably has a housing 38, in particular in the form of a cap, wherein preferably the sound generator 4A is arranged inside the housing 38 or is integrated into the housing 38. The housing 38 may have or be formed from several parts.

[0317] The protection element 3D and / or the sound generator 4A preferably has a switch 39 , an electronic module or electronic device 40 , a battery 41 , and / or an electroacoustic transducer 42 .

[0318] The sound generator 4A and / or the electroacoustic transducer 42 are preferably configured to generate the sound events 5A. The battery 41 is preferably configured to supply the electronics 40 and / or the transducer 42 with (electrical) energy.

[0319] The switch 39 is preferably configured to be actuated when the protection element 3D is removed from the body 3H, in particular the needle guard 34. Preferably, the switch 39 is a biased switch.

[0320] Preferably, the protective element 3D has a (preferably spring-loaded) pin 43, which is arranged between the body 3H or the needle guard 34 and the switch 39. When the protective element 3D is attached to the body 3H of the dispensing device 3, the pin 43 preferably contacts the switch 39 and / or the needle guard 34 or another part of the body 3H. However, other solutions are also possible here. In particular, the pin 43 can be omitted.

[0321] In particular, it is possible that the switch 39 or its actuating element is configured to be depressed by the body 3H and / or the pin 43 when the protective element 3D is attached to the body 3H, and / or that the switch 39 is actuated by moving the body 3H and the protective element 3D apart.

[0322] The switch 39 is preferably functionally coupled to an electronic module or device 40. The electronic device 40 is preferably configured to control an electroacoustic transducer 42 such that a sound event 5A is generated when the switch 39 is actuated.

[0323] The electronics 40 preferably has or forms a control and / or processor for controlling the electroacoustic transducer 42 .

[0324] The switch 39, the electronic device 40, the battery 41 and / or the electroacoustic transducer 42 are preferably arranged and / or mounted on and / or coupled via the printed circuit board 44. When the protection element 3D is attached to the body 3H, the electroacoustic transducer 42 is preferably arranged on the side of the printed circuit board 44 opposite to the body 3H.

[0325] The electroacoustic transducer 42 preferably comprises a piezoelectric transducer or a piezoelectric transducer or is formed by such a transducer.

[0326] The transducer 42 is preferably configured to generate sound events 5A having a frequency greater than 2 kHz and / or less than 40 kHz (in particular, a frequency of about 4 kHz and / or its harmonics or integer multiples, for example, 8 kHz, 12 kHz, 16 kHz and / or 20 kHz). It is particularly preferred that the sound events 5A have only frequencies in the ultrasonic range and / or frequencies greater than 16 kHz. It is particularly preferred that the sound events have a frequency of about 20 kHz. This has proven to be advantageous because, on the one hand, these frequencies cannot be detected by humans and therefore do not constitute an acoustic disturbance to humans. On the other hand, since there is less background noise in the ultrasonic range, it is preferably easier to detect the ultrasonic events 5A in the acoustic signal 6.

[0327] The electronic device 40 may also be configured to generate multiple and / or different sound events 5A using the transducer 42. The different sound events may differ, for example, in length, frequency, speed, loudness, spectral range, tone sequence and / or frequency, etc. In this way, the protection element 3D and / or the sound generator 4A and / or the sound events 5A may be adapted to different dispensing devices 3, in particular the substance 2 to be dispensed using the dispensing device 3, or be specific thereto.

[0328] The various aspects of the invention explained in the general part of the description and in the embodiments of the present application can in each case be implemented and can be advantageous both individually and in combination, even if not every possible advantageous combination is described individually.

[0329] Further aspects of the present invention are:

[0330] 1. A system for monitoring the preparation, execution and / or post-processing of an actual or simulated dispensing of an administrable, preferably pharmaceutical, substance, hereinafter referred to as a dispensing process, comprising:

[0331] a dispensing device for dispensing the substance, wherein the dispensing device has at least one sound generator, the at least one sound generator being designed to generate at least one sound event in the sound signal during the dispensing process, the sound event being specific for a property or a state change of the dispensing device, and

[0332] A detection device for checking the acoustic signal for the at least one sound event so as to enable detection of a change in a property or state of the dispensing device.

[0333] 2. A system according to aspect 1, characterized in that the one or more sound generators are designed so that the sound event or the plurality of sound events during the dispensing process are generated necessarily and in a reproducible manner.

[0334] 3. A system according to one of the preceding aspects, characterized in that the sound generator is a structure that is not required by the allocation process and / or is specially designed to generate the sound event.

[0335] 4. A system according to one of the preceding aspects, characterized in that the sound generator is or has a ratchet, clapper, vibrating bell, shaker, ringer or structure for generating reproducible plop, click, rattle, whistle, click, grating, rattle, hiss, squeak, buzz, ringing sounds, or is or has vibrations caused in particular by a stick-slip effect.

[0336] 5. A system according to one of the preceding aspects, characterized in that the protective element of the dispensing device has or forms the sound generator, wherein the protective element keeps the substance from being dispensed in an initial state and can be transformed into an activation state for initiating the dispensing of the substance as the sound event is generated.

[0337] 6. A system according to one of the preceding aspects, characterized in that the sound generator is configured to generate a sequence of more than two sound events in the sound signal, the sound events being separated from each other in time and following each other during the distribution process.

[0338] 7. A system according to one of the preceding aspects, characterized in that the dispensing device has at least two different sound generators, and the at least two different sound generators are designed to generate a first sound event and a second sound event that is preferably different from the first sound event in different stages of the dispensing process that succeed each other in time.

[0339] 8. System according to one of the preceding aspects, characterized in that the detection device for detecting a change in a property or state of the dispensing device by checking the acoustic signal is designed for the at least one sound event.

[0340] 9. A system according to aspect 8, characterized in that the detection device is designed to compare the sound signal with one or more sound event patterns and detect at least one sound event in the sound signal in this way, wherein the sound event pattern is previously known information corresponding to the sound event, similar to the sound event, or derived therefrom.

[0341] 10. The system according to aspect 9, characterized in that the detection device has a correlation module, and the correlation module is used to generate a correlation between the acoustic signal and the one or more sound event patterns.

[0342] 11. System according to any one of aspects 8 to 10, characterized in that the detection device is designed to, when at least one sound event is detected in the acoustic signal, determine a characteristic or a state change of the dispensing device based on the detected sound event.

[0343] 12. System according to one of the preceding aspects, characterized in that the detection device is designed to distinguish between different sound events of identical, similar or different dispensing devices.

[0344] 13. A system according to one of the preceding aspects, characterized in that the detection device has an output device for outputting the inspection result of the acoustic signal, preferably, wherein the detection device is designed to send a signal to the output device to notify the detection or to output a characteristic or state change of the distribution device or a characteristic value of the change.

[0345] 14. System according to one of the preceding aspects, characterized in that the detection device has or forms an analysis device for testing a plurality of sound events detected during the examination against a predetermined sequence or order.

[0346] 15. A system according to one of the preceding aspects, characterized in that the detection device is designed to output a result and output an error when the acoustic signal detects that the acoustic signal has a sequence of sound events that succeed each other in time and correspond to the steps of the allocation process, or when it detects that the acoustic signal does not have any sequence of sound events that succeed each other in time and correspond to the steps of the allocation process.

[0347] 16. A system according to one of the preceding aspects, characterized in that the system has multiple dispensing devices, which are distinguishable relative to the substance and the sound generator and are designed identically or similarly in other aspects, so that the same sound event or sound signal can be generated by the same or similar dispensing devices having the same characteristics relative to the substance, and different sound events and / or sound signals can be generated by the same or similar dispensing devices having different characteristics relative to the substance.

[0348] 17. A system according to one of the preceding aspects, characterized in that part of the dispensing device (preferably packaging, primary packaging, secondary packaging, cap, housing, protection system, mechanism, stopper, pressure generator, unlocking system, trigger system, flow path and / or dispensing device for spraying substance) has or forms the sound generator.

[0349] 18. A detection device for checking acoustic signals for sound events, wherein the sound events are generated by a sound generator of a dispensing device of a system according to one of the preceding aspects and are specific to a characteristic or state change of the dispensing device, the sound events being used to detect a dispensing process of the administerable, preferably medicinal, substance performed using the dispensing device.

[0350] 19. A method for monitoring the preparation, execution and / or post-processing of an actual or simulated dispensing of an administrable, preferably pharmaceutical, substance, hereinafter referred to as a dispensing process, wherein an acoustic signal is tested for a sound event specific to a change in a characteristic or state of the dispensing device, which sound event may be generated during the dispensing process.

[0351] 20. Use of a mobile terminal device, preferably a smart phone, a tablet computer and / or a wearable device, in particular a smart watch or a fitness armband, for checking an acoustic signal for at least one sound event specific to a change in a characteristic or state of a dispensing device, wherein the sound event can be generated using a sound generator of the dispensing system during the preparation, execution and / or post-processing of an actual or simulated dispensing of an administrable, preferably pharmaceutical substance, so as to enable detection of a change in a characteristic or state of the dispensing device, wherein the preparation, execution and / or post-processing of the actual or simulated dispensing is hereinafter referred to as the dispensing process.

[0352] 21. A computer program product having program code means, which, when implemented, executes the method according to aspect 19, in particular a computer-readable (preferably non-volatile) storage medium having instructions, which, when implemented on a processor, implement the method according to aspect 19.

[0353] Reference Symbols List

[0354] 1 System 22 Receiver

[0355] 2 Substance 23 Membrane

[0356] 3 Dispensing equipment 24 Adhesive

[0357] 3A Syringe 25 Accessories

[0358] 3B Injection needle 26 Spring arm

[0359] 3C Actuator 27 Drive element

[0360] 3D Protection Components 28 Part 1

[0361] 3E Surface Structure 29 Part 2

[0362] 3F Opposite structure 29A Sleeve element

[0363] 3G System 29B Compatible Components

[0364] 3H Body 30 Engagement Hook

[0365] 4A Sound generator 31 Joint element

[0366] 4B Sound generator 32A First sound generating element

[0367] 4C Sound generator 32B Second sound generating element

[0368] 4D Sound Generator 33 Pawl

[0369] 4E Sound Generator 34 Pin Protector

[0370] 5A Sound Event 35 Concave Cut

[0371] 5B Sound event 36A First guide element

[0372] 5C Sound event 36B Second guide element

[0373] 5D Sound event 36C Third guide element

[0374] 5E Sound Event 36D Fourth Guidance Element

[0375] 6 Signal 37 Arm

[0376] 7 Testing equipment 38 Housing

[0377] 8 Microphone 39 Switch

[0378] 9 Processor 40 Electronic Devices

[0379] 10 Output device 41 Battery

[0380] 11 Interface 42 Electroacoustic transducer

[0381] 12 Data Link 43 Pin

[0382] 13 Database 44 Printed Circuit Board

[0383] 14 Results

[0384] 15 Analysis equipment A axis

[0385] 16 Correlation module t1 time span

[0386] 17A First sound event mode t2 time span

[0387] 17B Second sound event mode t3 time span

[0388] 18 Secondary packaging t4 time span

[0389] 19 tear t5 time span

[0390] 20 Predetermined scoring line

[0391] 21 Primary packaging

Claims

1. A cap-shaped and / or cover-shaped protective element (3D) for a dispensing device (3) for dispensing an administrable medicinal substance (2), wherein The protective element (3D) has or forms a sound generator (4A-4E) which is designed to generate at least one reproducible sound event (5A-5E) in the acoustic signal (6) in preparation for the actual or simulated dispensing of the substance (2), the sound event (5A-5E) being specific to a property and / or a change in state of the dispensing device (3), Features The protection element (3D) has a first part and a second part (28, 29), the first part and the second part are movable relative to each other between an initial position and an activation position, wherein the protection element (3D) is configured to automatically generate the sound event (5A-5E) after reaching the activation position, and wherein the sound generator (4A-4E) is configured to generate the sound event (5A-5E) after the protection element (3D) moves from the initial position to the activation position and when the protection element (3D) returns from the activation position to the initial position, wherein the generated sound event (5A-5E) is independent of the way in which the protection element (3D) is manipulated.

2. The protection element according to claim 1, characterized in that: The protection element (3D) is configured to keep the substance (2) from being dispensed in an initial state of the dispensing device (3), and can be transformed into an activation state for initiating the dispensing of the substance (2) as the sound event (5A-5E) is generated.

3. The protection element according to claim 1 or 2, characterized in that: The protection element (3D) is configured to generate the sound events (5A-5E) when the protection element (3D) is removed from the body (3H) of the dispensing device (3), wherein the generated sound events (5A-5E) are independent of the speed, force and / or other external parameters used to remove the protection element (3D) from the body (3H).

4. The protection element according to claim 1 or 2, characterized in that: The protection element (3D) has a drive element (27), which is configured to be activated by manipulating the protection element (3D) so as to reach the activation position, and / or to automatically, immediately and / or necessarily cause the generation of the sound event (5A-5E) after the protection element (3D) has reached the activation position.

5. The protection element according to claim 4, characterized in that: The driving element (27) is a spring.

6. The protection element according to claim 1 or 2, characterized in that: The first part (28) is a cap and the second part (29) is a sleeve arranged inside the cap, wherein the protective element (3D) has a latch mechanism or stop for preventing the sleeve from being removed from the cap.

7. The protection element according to claim 1 or 2, characterized in that: The protection element (3D) has a damping device for controlling, damping and / or reducing the speed and / or acceleration of the movement of the protection element (3D) from the activation position to the initial position.

8. The protection element according to claim 1 or 2, characterized in that: The protection element (3D) has a guide (36A-36C), which is configured so that when the protection element (3D) moves from the initial position to the activation position, the sound generating elements (32A, 32B) of the sound generator (4A-4E) do not interact with each other, and so that when the protection element (3D) moves from the activation position to the initial position, the sound generating elements (32A, 32B) interact with each other and generate the sound event (5A-5E).

9. The protection element according to claim 8, characterized in that: The sound generating elements (32A, 32B) interact mechanically.

10. The protection element according to claim 1 or 2, characterized in that: The sound generator (4A-4E) has one or more sound generating elements (32A, 32B) that are attachable to, detachable from and / or replaceable from the protective element (3D).

11. The protection element according to claim 1 or 2, characterized in that: The sound generator (4A-4E) has an electroacoustic transducer (42) or is formed by the electroacoustic transducer, wherein the protection element (3D) has a switch (39) and an electronic device (40), wherein the switch (39) is configured to be actuated when the protection element (3D) is removed from the body (3H) of the dispensing device (3), and wherein the electronic device (40) is configured to control the electroacoustic transducer (42) so that the sound event (5A-5E) is generated when the switch (39) is actuated.

12. The protection element according to claim 11, characterized in that: The sound generator (4A-4E) and / or the electroacoustic transducer (42) are configured to generate sound events (5A-5E) having a frequency within the ultrasonic range.

13. The protection element according to claim 12, characterized in that: The frequency is 20 kHz.

14. A dispensing device (3) for dispensing an administrable medicinal substance (2), the dispensing device having a body (3H) and a protective element (3D), the protective element being cap-shaped and / or in the form of a cover, wherein the dispensing device (3) has at least one sound generator (4A-4E), the at least one sound generator being designed to generate at least one reproducible sound event (5A-5E) in an acoustic signal (6) in preparation for actual or simulated dispensing of the substance (2), the sound event (5A-5E) being specific to a property and / or a change of state of the dispensing device (3), It is characterized in that The protection element (3D) is configured according to any one of claims 1-13.

15. The dispensing device according to claim 14, characterized in that The dispensing device (3) is configured to move the protective element (3D) into the activated position during removal of the protective element (3D) and / or the first portion from the body (3H).

16. Dispensing device according to claim 14 or 15, characterized in that The dispensing device (3) is configured to hold the second part (29) in a fixed position relative to the main body (3H) during the removal of the protection element (3D) and / or the first part (28) from the main body (3H), and to move the protection element (3D) from the initial position to the activated position by moving the first part (28) relative to the second part (29) and / or the main body (3H).

17. Dispensing device according to claim 14 or 15, characterized in that The dispensing device (3) is configured to release the second part (29) when the protection element (3D) has reached the activation position or the activated position and the protection element (3D) and / or the first part (28) is moved further away from the body (3H).

18. A system for monitoring the preparation, execution and / or post-processing of an actual or simulated dispensing of an administrable pharmaceutical substance (2), the preparation, execution and / or post-processing of the actual or simulated dispensing being referred to as a dispensing process, the system comprising: Dispensing device according to any one of claims 14 to 17, wherein the dispensing device (3) has at least one sound generator (4A-4E) which is designed to generate at least one sound event (5A-5E) in the acoustic signal (6) during the dispensing process, the sound event (5A-5E) being specific to a property or a change of state of the dispensing device (3), and A detection device (7) for checking the acoustic signal (6) for the at least one sound event (5A-5E) in order to enable detection of a change in a property or state of the dispensing device (3).

19. The system according to claim 18, characterized in that One or more sound generators (4A-4E) are designed such that the sound event (5A-5E) or multiple sound events (5A-5E) during the dispensing process are generated necessarily and in a reproducible manner.

20. The system according to claim 18 or 19, characterized in that The sound generators (4A-4E) are structures that are not required by the allocation process and / or are specifically designed to generate the sound events (5A-5E).

21. The system according to claim 18 or 19, characterized in that The protection element (3D) of the dispensing device (3) has or forms the sound generator (4A-4E), wherein the protection element (3D) keeps the substance (2) from being dispensed in an initial state and can be transformed into an activation state for initiating the dispensing of the substance (2) as the sound event (5A-5E) is generated.

22. The system according to claim 18 or 19, characterized in that The sound generator (4A-4E) is configured to generate in the acoustic signal (6) a sequence of more than two sound events (5A-5E), the sound events (5A-5E) being separated in time from one another and following one another in the course of the dispensing process.

23. The system according to claim 18 or 19, characterized in that The dispensing device (3) has at least two different sound generators (4A-4E) which are designed to generate a first sound event and a second sound event in different phases of the dispensing process which follow one another in time.

24. The system according to claim 23, characterized in that The second sound event is different from the first sound event.

25. The system according to claim 18 or 19, characterized in that The detection device (7) is designed to detect a change in a property or state of the dispensing device (3) by checking the acoustic signal (6) for the at least one sound event (5A-5E).

26. The system according to claim 25, characterized in that The detection device (7) is designed to compare the sound signal (6) with one or more sound event patterns (17A, 17B), and in this way detect at least one sound event (5A-5E) in the sound signal (6), wherein the sound event pattern (17A, 17B) is previously known information corresponding to the sound event (5A-5E), similar to the sound event (5A-5E), or derived therefrom.

27. The system according to claim 26, characterized in that The detection device (7) has a correlation module (16) for generating a correlation between the acoustic signal (6) and the one or more sound event patterns (17A, 17B).

28. The system according to claim 25, characterized in that The detection device (7) is designed to, when at least one sound event (5A-5E) is detected in the acoustic signal (6), determine a property or a change of state of the dispensing device (3) based on the detected sound event (5A-5E).

29. The system according to claim 18 or 19, characterized in that The detection device (7) has or forms an analysis device (15) for testing a plurality of sound events (5A-5E) detected during the examination against a predetermined sequence or order.

30. The system according to claim 18 or 19, characterized in that The system (1) has a plurality of dispensing devices (3), which are distinguishable with respect to the substance (2) and the sound generator (4A-4E) and are designed identically or similarly in other aspects, so that the same sound event (5A-5E) or sound signal (6) can be generated by the same or similar dispensing devices (3) having the same characteristics with respect to the substance (2), and different sound events (5A-5E) and / or sound signals (6) can be generated by the same or similar dispensing devices (3) having different characteristics with respect to the substance (2).

31. A detection device (7) for checking an acoustic signal (6) for a sound event (5A-5E), the sound event being generated by a sound generator (4A-4E) of a dispensing device (3) of a system (1) according to claim 18 or 19 and being specific to a characteristic or state change of the dispensing device (3), the detection device being used to detect a dispensing process of the administrable drug substance (2) performed using the dispensing device (3).

32. A method for monitoring the preparation, execution and / or post-processing of an actual or simulated dispensing of an administrable drug substance (2), the preparation, execution and / or post-processing of the actual or simulated dispensing being referred to as a dispensing process, wherein an acoustic signal (6) is tested for a specific sound event (5A-5E) corresponding to a change in a characteristic or state of a dispensing device (3) for dispensing the administrable drug substance (2), the sound event being generated in the case of the dispensing process by a method according to a protective element (3D) as described in any one of claims 1-13.

33. Use of a mobile terminal device for checking an acoustic signal (6) for at least one sound event (5A-5E) specific to a change in a characteristic or state of a dispensing device (3), the sound event being generated during the preparation, execution and / or post-processing of an actual or simulated dispensing of an administrable drug substance (2) using a sound generator (4A-4E) of a protective element (3D) according to any one of claims 1-13, so as to be able to detect a change in a characteristic or state of the dispensing device (3).

34. The use according to claim 33, wherein the mobile terminal device is a smart phone, a tablet computer and / or a wearable device.

35. The use according to claim 33, wherein the mobile terminal device is a smart watch or a fitness armband.

Images